What changed in this filing

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Item 1A. Risk Factors

2022-03-23 compared with 2021-03-17 · 1491 added, 1247 removed, 130 unchanged (95% of the section changed)

should carefully consider the risks described below, as well as other information contained in this report, including the consolidated

financial statements and the notes thereto and “Management’s Discussion and Analysis of Financial Condition and Results

of Operations.”

The occurrence of any of the events discussed below could significantly and adversely affect our business,

prospects, results of operations, financial condition, and cash flows.

financial statements and the notes thereto and “Management’s Discussion and Analysis of Financial Condition and Results of

Operations.” The occurrence of any of the events discussed below could significantly and adversely affect our business, prospects,

results of operations, financial condition, and cash flows.

business is subject to numerous risks and uncertainties that you should consider before investing in our common stock.

1 unchanged sentence

is a summary of the principal risk factors we face:

have incurred significant losses since our inception, expect to incur losses over the next several years and may never achieve

or maintain profitability.

have no history of commercializing products.

will need additional funding to pursue our business objectives.

allocated a significant amount of time and resources into developing a treatment for COVID-19, and these efforts may ultimately

be unfruitful.

business and operations may be adversely affected by the evolving and ongoing COVID-19 pandemic.

regulatory approval processes of the FDA and other government authorities are lengthy, time consuming and inherently unpredictable.

we are unable to successfully develop, receive regulatory approval for and commercialize our product candidates, our business

will be harmed.

if we do commercialize one or more products, most pharmaceutical products that achieve commercialization still do not recoup

their cost of capital.

face uncertainties with respect to new United States healthcare legislation which may lead to reduced pricing, among other

cost of our research and development programs may be higher than expected, and there is no assurance that such efforts will

be successful in a timely manner or at all.

in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials.

may not be successful in our efforts to research, develop, or in-license or acquire product candidates.

face intense competition, which may limit or eliminate our commercial prospects with respect to product candidates.

rely on third parties to research, develop and commercialize certain product candidates, and such third parties may not perform

satisfactorily or act in our best interests.

we are unable to obtain or protect intellectual property rights related to any of our product candidates, we may not be able

to compete effectively in the market.

may become subject to expensive intellectual property litigation to enforce our intellectual property rights or defend against

claims asserted by others.

trading price and volume of our common stock may be volatile, and could decline in which case investors could lose all or

part of their investment.

We have incurred significant

losses since our inception, expect to incur losses over the next several years and may never achieve or maintain profitability.

We have no history of commercializing

We will need additional

funding to pursue our business objectives, including to eventually commercialize our product candidates if we complete research and

development efforts and receive the required regulatory approvals for a product candidate in the future.

We allocated a significant

amount of time and resources into developing a treatment for COVID-19, and these efforts may ultimately be unfruitful.

Our business and operations

may be adversely affected by the evolving and ongoing COVID-19 pandemic.

The regulatory approval

processes of the FDA and other government authorities are lengthy, time consuming and inherently unpredictable.

If we are unable to successfully

develop, receive regulatory approval for and commercialize our product candidates, our business will be harmed.

Even if we do commercialize

one or more products, most pharmaceutical products that achieve commercialization still do not recoup their cost of capital.

We face uncertainties with

respect to the potential for new United States healthcare legislation which may lead to reduced pricing, among other things.

The cost of our research

and development programs may be higher than expected, and there is no assurance that such efforts will be successful in a timely

manner or at all.

Success in preclinical

studies or earlier clinical trials may not be indicative of results in future clinical trials or an ability to ultimately receive

approval from the FDA.

We may not be successful

in our efforts to research, develop, or in-license or acquire product candidates.

We face intense competition,

which may limit or eliminate our commercial prospects with respect to product candidates.

We rely on third parties

to research, develop and commercialize certain product candidates, and such third parties may not perform satisfactorily or act in

our best interests.

If we are unable to obtain

or protect intellectual property rights related to any of our product candidates, we may not be able to compete effectively in the

We may become subject to

expensive intellectual property litigation to enforce our intellectual property rights or defend against claims asserted by others.

Our common stock may be

delisted if we fail to meet and maintain Nasdaq’s minimum bid price requirement, including regaining compliance in connection

with our current closing bid price deficiency which we are required to remedy by May 16, 2022 absent an extension.

The trading price and volume

of our common stock may be volatile, and could decline in which case investors could lose all or part of their investment.

RELATED TO OUR BUSINESS

business has been and may continue to be affected by the COVID-19 pandemic, and the full extent of such impact remains uncertain.

United States and global impact from the COVID-19 virus has had and/or will have a material adverse effect on us in a number of

ways including:

our scientists and other personnel (or their family members) are infected with the virus, it may hamper our ability to engage

in ongoing research activities;

the third parties on whom we rely can be similarly impacted;

these third parties are affected by COVID-19, they may focus on other activities which they may devote their limited time

to other priorities rather than to our joint research;

have experienced and may in the future experience supply chain disruptions, including shortages, delays and price increases

in laboratory equipment and supplies, which would impact our research activities.

For example, supply shortages caused by

the pandemic have delayed the development of our influenza A virus program;

a result of the continuing impact of the virus, we may fail to get access to third party laboratories which would impact our

research activities;

may face challenges related to restrictions and efforts to avoid further spread of the virus, in our efforts the conduct our

planned clinical trials consistent with normally applicable approaches and good clinical practice standards, and although

regulators including the FDA have offered guidance applicable during the COVID-19 pandemic allowing for flexibility of standards

in certain areas and alternate methods of meeting trial oversight obligations (for example, via remote monitoring), the potential

impact of these challenges cannot be fully predicted at this time.

may encounter difficulties enrolling patients for our contemplated Phase 1 clinical trial or in conducting that trial due

to government actions to contain the outbreak or general public concern;

may fail to appropriately allocate resources or adapt to the rapidly evolving market and regulatory environment caused by

the pandemic, including with respect to our efforts to develop a treatment for COVID-19;

the FDA continues to focus its efforts on the pandemic, there may be material delays in our IND application for our Influenza

A Phase 1 study;

may sustain problems due to the serious short-term and possible longer term economic

disruptions and market volatility as the U.S.

and global economy faces unprecedented

have never generated revenue from product sales and all of our product candidates are currently in the pre-clinical and early

clinical stage, we may continue to incur significant losses for the foreseeable future and never generate revenue from product

United States and global impact from the COVID-19 virus has had and/or will have a material adverse effect on us in a number of ways

If our scientists

and other personnel (or their family members) are infected with the virus, it may hamper our ability to engage in ongoing research

the third parties on whom we rely have been and may in the future be adversely impacted, which can materially adversely affect our

operations and financial condition.

For example, beginning in 2021 our CROs have experienced serious operational issues due to the

spread of the Omicron variant, and throughout the pandemic in general we have experienced delays with our CROs and CMOs arising from

challenges such as facility shutdowns, personnel illness, shortages of trained scientists, local COVID-19 policies and safety measures,

and supply chain issues including with animals for preclinical studies, which in each case has resulted in material delays and/or

cost increases in our research and development efforts;

If these third parties

continue to be affected by COVID-19, they may focus on other activities which they may devote their limited time to other priorities

rather than to our joint research;

We have experienced and

may in the future experience supply chain disruptions, including shortages, delays and price increases in laboratory equipment and

supplies, which would impact our research activities.

For example, supply shortages caused by the pandemic delayed the development

of our Influenza A virus program and may impact our COVID-19 programs;

As a result of the continuing

impact of the virus, we may fail to get access to third party laboratories which would impact our research activities;

We may face challenges

related to restrictions and efforts to avoid further spread of the virus, in our efforts to conduct our planned clinical trials consistent

with normally applicable approaches and good clinical practice standards, and although regulators including the FDA have offered

guidance applicable during the COVID-19 pandemic allowing for flexibility of standards in certain areas and alternate methods of

meeting trial oversight obligations (for example, via remote monitoring), the potential impact of these challenges cannot be fully

predicted at this time.

CROs we contract

with may encounter difficulties enrolling patients for our Phase 1 clinical trials or in conducting that trial due to government

actions to contain the outbreak or general public concern;

We may fail to appropriately

allocate resources or adapt to the rapidly evolving market and regulatory environment caused by the pandemic, including with respect

to our efforts to develop a treatment for COVID-19;

As the FDA continues to

focus its efforts on the pandemic, there may be material delays in our IND application for our planned Phase 1 studies;

We may sustain problems

due to the serious short-term and possible longer term economic disruptions and market volatility as the U.S.

and global economy

faces unprecedented uncertainty.

have never generated revenue from product sales and all of our product candidates are currently in the pre-clinical and early clinical

stage, and we may continue to incur significant losses for the foreseeable future and never generate revenue from product sales.

are a pre-clinical and early stage clinical, biopharmaceutical discovery and development company.

We currently expect to initiate

a Phase 1 clinical trial for our Influenza A product candidate in the third quarter of 2021, although with the FDA’s focus

on the COVID-19 pandemic it is possible it could be delayed.

Because of the need to complete clinical trials, establish safety

and efficacy and obtain regulatory approval, which is an expensive and time-consuming process, we do not anticipate generating

revenue from product sales for at least five years and will continue to sustain considerable losses.

We may develop a partnership

that could generate income sooner, but there is no guarantee that will be achievable.

had an accumulated deficit of $245,000,000 from inception through December 31, 2020 and expect to continue losing money in the

We have initiated a Phase 1

clinical trial for our Influenza A product candidate in the first quarter of 2022, which has been delayed due to challenges with

CROs arising from the recent Omicron variant of COVID-19.

We also plan to commence two COVID-19 clinical trials in 2022 for product candidates.

An IND is required by the FDA in order to proceed from pre-clinical to clinical trials for a product candidate.

of the need to complete clinical trials, establish safety and efficacy and obtain regulatory approval, which is an expensive and time-consuming

process, we do not anticipate generating revenue from product sales for at least five years and will continue to sustain considerable

We may develop a partnership that could generate income sooner, but there is no guarantee that will be achievable.

had an accumulated deficit of $259,093,000 from inception through December 31, 2021 and expect to continue losing money in the future.

We may never achieve income from operations or have positive cash flow from operations .

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It is likely that we will need to raise additional capital in the future.

There can be no assurance that we will ever generate income from operations or have positive cash flow from operations.

we have yet to generate any revenue from product sales on which to evaluate our potential for future success and to determine

if we will be able to execute our business plan, it is difficult to evaluate our prospects and the likelihood of success or failure

of our business.

can be no assurance that we will ever generate income from operations or have positive cash flow from operations.

we have yet to generate any revenue from product sales on which to evaluate our potential for future success and to determine if we will

be able to execute our business plan, it is difficult to evaluate our prospects and the likelihood of success or failure of our business.

ability to generate revenue from product sales and achieve profitability depends on our ability, alone or with partners, to successfully

complete the development of, obtain the regulatory approvals for and commercialize pharmaceutical product candidates.

no pharmaceutical product candidates that have generated any commercial revenue, do not expect to generate revenues from the commercial

sale of pharmaceutical products for foreseeable future, and might never generate revenues from the sale of pharmaceutical products.

Our ability to generate revenue and achieve profitability will depend on, among other things, the following:

and validating new therapeutic strategies;

into collaborations with large pharmaceutical or biotechnology companies, similar to our Collaboration Agreement with Merck;

our research and preclinical development of pharmaceutical product candidates;

and completing clinical trials for pharmaceutical product candidates;

and obtaining regulatory marketing approvals for pharmaceutical product candidates that successfully complete clinical trials;

and maintaining supply and manufacturing relationships with third parties;

and commercializing pharmaceutical product candidates for which we obtain regulatory marketing approval, with a partner or,

if launched independently, successfully establishing a sales force, marketing and distribution infrastructure;

protecting, enforcing, defending and expanding our intellectual property portfolio;

hiring and retaining qualified personnel.

of the numerous risks and uncertainties associated with pharmaceutical product development, we cannot predict the timing or amount

of increased expenses and when we will be able to achieve or maintain profitability, if ever.

Our expenses could increase beyond

expectations if we are required by regulatory agencies to perform additional unanticipated studies and trials.

if one or more pharmaceutical product candidates we independently develop is approved for commercial sale, we anticipate incurring

significant costs associated with commercializing any approved pharmaceutical product candidate.

Moreover, even if we can generate

revenues from the sale of any approved pharmaceutical products, we may not become profitable and may need to obtain additional

funding to continue operations.

early-stage drug development requires major capital investment, as we continue to incur operating losses, we will need to raise

additional capital or form strategic partnerships to support our research and development activities in the future.

We have no pharmaceutical

product candidates that have generated any commercial revenue, do not expect to generate revenues from the commercial sale of pharmaceutical

products for foreseeable future, and might never generate revenues from the sale of pharmaceutical products.

Our ability to generate

revenue and achieve profitability will depend on, among other things, the following:

identifying and validating

new therapeutic strategies;

entering into collaborations

with large pharmaceutical or biotechnology companies, similar to our Collaboration Agreement with Merck;

completing our research

and preclinical development of pharmaceutical product candidates;

initiating and completing

clinical trials for pharmaceutical product candidates;

seeking and obtaining regulatory

marketing approvals for pharmaceutical product candidates that successfully complete clinical trials;

establishing and maintaining

supply and manufacturing relationships with third parties;

launching and commercializing

pharmaceutical product candidates for which we obtain regulatory marketing approval with a partner or, if launched independently,

successfully establishing a sales force, marketing and distribution infrastructure;

maintaining, protecting,

enforcing, defending and expanding our intellectual property portfolio;

attracting, hiring and

retaining qualified personnel.

of the numerous risks and uncertainties associated with pharmaceutical product development, we cannot predict the timing or amount of

increased expenses and when we will be able to achieve or maintain profitability, if ever.

Our expenses could increase beyond expectations

if we are required by regulatory agencies to perform additional unanticipated studies and trials.

if one or more pharmaceutical product candidates we independently develop is approved for commercial sale, we anticipate incurring significant

costs associated with commercializing any approved pharmaceutical product candidate.

Moreover, even if we can generate revenues from

the sale of any approved pharmaceutical products, we may not become profitable and may need to obtain additional funding to continue

early-stage drug development requires major capital investment, as we continue to incur operating losses, we will need to raise additional

capital or form strategic partnerships to support our research and development activities in the future.

are still in the early stages of development of our product candidates and have no products approved for commercial sale or presently

in clinical trials.

Although our Hepatitis C product advanced through Phase 2a, we are seeking a partner to fund and oversee that

product candidate’s further development.

As stated earlier, we expect to initiate a Phase 1 clinical trial for our Influenza

A product in the third quarter.

Developing pharmaceutical products, including conducting preclinical studies and clinical trials,

is capital-intensive.

As a rule, research and development expenses increase substantially as we advance our product candidates

toward clinical programs.

We currently have one hepatitis C product candidate that has completed a Phase 2a clinical trial and

have secured funding of the research and development of influenza A/B product candidates under our Collaboration Agreement with

See “Item 1 –

Business –

Collaborations –

Merck Collaboration.”

However, in order to conduct

trials for our other product candidates, including our potential COVID-19 therapy, we will need to raise additional capital to

support our operations or form partnerships, in addition to our existing collaborative alliances, which may give substantial rights

to a partner.

Such funding or partnerships may not be available to us on acceptable terms, or at all.

Moreover, any future financing

may be very dilutive to our existing stockholders.

we move lead compounds through toxicology and other preclinical studies, also referred to as nonclinical studies, we have and

we will be required to file an Investigational New Drug application (“IND”) or its equivalent in foreign countries,

and as we conduct clinical development of product candidates, we may have adverse results that may cause us to consume additional

Our partners may not elect to pursue the development and commercialization of our product candidates subject to our respective

agreements with them.

These events may increase our development costs more than we expect.

We may need to raise additional capital

or otherwise obtain funding through strategic alliances if we initiate clinical trials for new product candidates other than programs

currently partnered.

We will require additional capital to obtain regulatory approval for, and to commercialize, product candidates.

securing additional financing, such additional fundraising efforts may divert our management’s attention from our day-to-day

activities, which may adversely affect our ability to develop and commercialize product candidates.

We cannot guarantee that future

financing will be available in sufficient amounts or on terms acceptable to us, if at all.

If we cannot raise additional capital

when required or on acceptable terms, we may be required to:

terms that restrict our ability to issue securities, incur indebtedness, or otherwise raise capital in the future, or restrict

our ability to pay dividends or engage in acquisitions;

significantly

delay, scale back or discontinue the development or commercialization of any product candidates;

strategic alliances for research and development programs at an earlier stage than otherwise would be desirable or on terms

less favorable than might otherwise be available;

or license on unfavorable terms, our rights to technologies or any product candidates we otherwise would seek to develop or

commercialize ourselves.

we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we will be prevented from pursuing

development and commercialization efforts, which will have a material adverse effect on our business, operating results and prospects

or may render the Company unable to continue operations.

we are unable to rely on certain exemptions from registration under the federal securities laws, as the result of a “disqualifying

involving a director of the Company, it could adversely affect our ability to obtain future private financing.

January 10, 2019, Dr.

Phillip Frost, one of our directors, was permanently enjoined from violating a certain anti-fraud provision

of the Securities Act of 1933 (the “Securities Act”), future violations of Section 13(d) of the Exchange Act and Rule

13d-1(a) thereunder and participating in penny stock offerings with certain exceptions.

So long as Dr.

Frost is a director or

until five years have passed since the injunction, the Company will be unable to rely on certain exemptions from registration

including the exemptions under Rule 506 and Regulation A promulgated under the Securities Act absent a waiver issued by the Securities

and Exchange Commission (the “SEC”).

We have not applied for a waiver, and even if we do, the SEC may choose not to

grant us a waiver.

While there is a statutory exemption for private placements under Section 4(a)(2) of the Securities Act, the

absence of the Rule 506 safe harbor under Regulation D could adversely affect our ability to raise necessary capital in private

It has not and will not affect our ability to raise capital in registered public offerings.

As stated earlier, we initiated a Phase 1 clinical trial for our Influenza A product and also plan to initiate

two COVID-19 product candidates in 2022.

However, our ability to conduct clinical trials in a cost-effective manner and within the

desired timeframes remains subject to uncertainties arising from COVID-19 (including the pandemic’s effect on third parties on

which we rely), supply chain shortages, and potential difficulties in obtaining adequate participant enrollments.

Further, developing

pharmaceutical products, including conducting preclinical studies and clinical trials, is capital-intensive.

As a rule, research and

development expenses increase substantially as we advance our product candidates toward clinical programs.

If we are able to advance

our products through clinical trials, we may need to raise additional capital to support our operations and/or form partnerships, in

addition to our existing collaborative alliances, which may give substantial rights to a partner.

Such funding or partnerships may not

be available to us on acceptable terms, or at all.

Moreover, any future financing may be very dilutive to our existing stockholders.

we move lead compounds through toxicology and other preclinical studies, also referred to as nonclinical studies, we have and we will

be required to file an IND or its equivalent in foreign countries, and as we conduct clinical development of product candidates, we may

have adverse results that may cause us to consume additional capital.

Our partners may not elect to pursue the development and commercialization

of our product candidates subject to our respective agreements with them.

These events may increase our development costs more than we

We may need to raise additional capital or otherwise obtain funding through strategic alliances if we initiate clinical trials

for new product candidates other than programs currently partnered.

We will require additional capital to obtain regulatory approval

for, and to commercialize, product candidates.

securing additional financing, such additional fundraising efforts may divert our management’s attention from our day-to-day activities,

which may adversely affect our ability to develop and commercialize product candidates.

We cannot guarantee that future financing will

be available in sufficient amounts or on terms acceptable to us, if at all.

If we cannot raise additional capital when required or on

acceptable terms, we may be required to:

accept terms that restrict

our ability to issue securities, incur indebtedness, or otherwise raise capital in the future, or restrict our ability to pay dividends

or engage in acquisitions;

significantly delay, scale

back or discontinue the development or commercialization of any product candidates;

seek strategic alliances

for research and development programs at an earlier stage than otherwise would be desirable or on terms less favorable than might

otherwise be available;

relinquish or license on

unfavorable terms, our rights to technologies or any product candidates we otherwise would seek to develop or commercialize ourselves.

we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we will be prevented from pursuing development

and commercialization efforts, which will have a material adverse effect on our business, operating results and prospects or may render

the Company unable to continue operations.

RELATED TO THE DISCOVERY, DEVELOPMENT AND COMMERCIALIZATION OF PRODUCT CANDIDATES

COVID-19 program is in the preclinical stage and we face significant competition from major companies who have developed vaccines

or COVID-19 treatments.

If we fail to gain market share because our competitors develop and successfully commercialize effective

COVID-19 vaccines or therapies or if we fail to obtain or maintain FDA authorization or to otherwise account for uncertainties

surrounding the virus, our business and future prospects could be materially and adversely affected.

COVID-19 program is in the preclinical stage.

We initiated preclinical studies during the second quarter of 2020 and selected

the lead preclinical molecule in the fourth quarter of 2020.

We may be unable to produce an effective therapy in a timely manner

Additionally, we are committing substantial financial and other resources to our COVID-19 program, which may negatively

impact our other programs.

Further, in the wake of the global COVID-19 pandemic a number of third parties, including large biotechnology

and pharmaceutical companies and academic institutions have developed vaccines, at least three of which have FDA approval and

have FDA approval for the treatment of hospitalized patients for, or a vaccine against, COVID-19.

Some of these large pharmaceutical

companies, including Pfizer, Moderna and Janssen Biotech, Inc., have obtained emergency use authorization from the FDA for vaccines

which have demonstrated high efficacy rates and are currently being distributed to the general population, with an initial priority

to the elderly and other more vulnerable individuals.

While our COVID-19 program is focused on treatment rather than prevention,

widespread vaccination limits our prospects with respect to any therapeutic product candidate we develop.

some of our competitors that are also developing treatments for the virus have substantially more resources, including government

funding, than we do and have existing products in significantly more advanced stages of development.

For example, the FDA approved

remdesivir, an investigational antiviral agent developed by Gilead Sciences, Inc.

(“Gilead”), for the treatment of

patients with COVID-19 requiring hospitalization.

In addition, the FDA has issued an emergency use authorization for the investigational

monoclonal antibody therapy for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.

At least one other

competitor is conducting a combination Phase II/III clinical trial for a treatment using cannabidiol to treat COVID-19 for patients

with heart issues.

Even if we do obtain FDA authorization for a therapeutic product, the FDA may subsequently rescind or limit

such authorization as more information about the product, including its efficacy and side effects, becomes available.

this virus is highly mutative and a number of strains have already arisen, and any treatment we are able to develop and commercialize

will therefore remain subject to the risk that a mutation will occur that produces a strain or strains of the virus to which such

treatment has a diminished effect or is ineffective.

If we are unable to timely advance our COVID-19 program, or if we fail to

gain or maintain a market share as a result of our competitors developing and successfully commercializing vaccines and effective

COVID-19 therapies more quickly than we do, our business and future prospects could be materially and adversely affected.

COVID-19 programs are in the preclinical stage and we face significant competition from major companies who have developed vaccines or

COVID-19 treatments.

If we fail to gain market share because our competitors develop and successfully commercialize effective COVID-19

vaccines or therapies or if we fail to obtain or maintain FDA authorization or to otherwise account for uncertainties surrounding the

virus, our business and future prospects could be materially and adversely affected.

we plan to commence IND-enabling studies for two COVID-19 products in 2022, our COVID-19 programs are still in the preclinical stage.

We may be unable to produce an effective therapy in a timely manner or at all.

Additionally, we are committing substantial financial

and other resources to our COVID-19 program, which may negatively impact our other programs.

Further, in the wake of the global COVID-19

pandemic a number of third parties, including large biotechnology and pharmaceutical companies and academic institutions have developed

vaccines, at least two of which have FDA approval.

Some competitors have also received FDA approval or emergency use authorization for

the treatment of COVID-19.

Some of these large pharmaceutical companies, including Pfizer, Moderna and Janssen

Biotech, Inc., have obtained FDA approval for vaccines which have demonstrated high efficacy rates and are currently being distributed

to the general population above the age of five, with the FDA currently reviewing applications for reducing the age for which certain

vaccines are approved to six months and older.

While our COVID-19 program is focused on treatment rather than prevention, widespread

vaccination limits our prospects with respect to any therapeutic product candidate we develop.

some of our competitors that are also developing treatments for the virus have substantially more resources, including government funding,

than we do and have existing products in significantly more advanced stages of development.

For example, the FDA approved remdesivir,

an investigational antiviral agent developed by Gilead for the treatment of patients with COVID-19

requiring hospitalization.

In addition, the FDA has issued an emergency use authorization for the investigational monoclonal antibody

therapy for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.

At least one other competitor is conducting a

combination Phase 2/3 clinical trials for a treatment using cannabidiol to treat COVID-19 for patients with heart issues.

Another competitor

is conducting Phase 2 clinical trials for the treatment of “long” COVID, also known as post-COVID syndrome, for patients

who experience symptoms for more than four weeks.

Even if we do obtain FDA authorization for a therapeutic product, the FDA may subsequently

rescind or limit such authorization as more information about the product, including its efficacy and side effects, becomes available.

Further, this virus is highly mutative and a number of variants have already arisen, and any treatment we are able to develop and commercialize

will therefore remain subject to the risk that a mutation will occur that produces a strain or strains of the virus to which such treatment

has a diminished effect or is ineffective.

For example, the recent Omicron variant of the virus is more resistant to treatments that

were effective against prior variants of the virus.

If we do develop a treatment that is effective against a current variant, a later

variant may arise that reduces or eliminates the product’s efficacy before we are able to commercialize it.

Further, if this occurs,

one or more competitors’ products may be more effective against new variants than ours, resulting in a diminished market for our

For example, on February 11, 2022, the FDA announced its emergency use authorization for bebtelovimab, a new monoclonal antibody

for the treatment of COVID-19 by non-hospitalized patients, that retains activity against the Omicron variant.

If we are unable to timely

advance our COVID-19 program, or if we fail to gain or maintain a market share as a result of our competitors developing and successfully

commercializing vaccines and effective COVID-19 therapies more quickly than we do, our business and future prospects could be materially

and adversely affected.

will depend on Merck for the successful research, development and commercialization of our Influenza A/B product candidates.

1 unchanged sentence

Influenza A/B antiviral agents.

On January 19, 2021, the Company announced that it had completed all research obligations under

the Collaboration Agreement with Merck, and Merck is now solely responsible for further development of the influenza A/B antiviral

compounds, and will also be solely responsible for the commercialization of any products derived therefrom.

See “Item 1

Business –

Collaborations –

Merck Collaboration”

for more information on the Collaboration Agreement.

As such, the success of this collaborative alliance will depend on the efforts and activities of Merck, particularly moving forward.

our research collaboration with Merck is terminated or is otherwise unsuccessful, including failure to reach milestones, we would

not receive milestone payments or royalties, which could materially and adversely affect our ability to successfully develop and

commercialize influenza A/B product candidates and our future financial condition.

On January 19, 2021, the Company announced that it had completed all research obligations under the Collaboration

Agreement with Merck, and Merck is now solely responsible for further development of the Influenza A/B antiviral compounds, and will

also be solely responsible for the commercialization of any products derived therefrom.

See “Item 1 – Business – Collaborations

– Merck Collaboration” for more information on the Collaboration Agreement.

As such, the success of this collaborative alliance

will depend on the efforts and activities of Merck, particularly moving forward.

our research collaboration with Merck is terminated or is otherwise unsuccessful, including failure to reach milestones, we would not

receive milestone payments or royalties, which could materially and adversely affect our ability to successfully develop and commercialize

Influenza A/B product candidates and our future financial condition.

to the terms of the Collaboration Agreement, Merck agreed to, among other things, (i) fund the research and development collaboration,

including clinical development and commercialization;

(ii) make certain milestone payments up to a total of $156 million, including

payments associated with the successful product development and attainment of certain U.S.

and EU regulatory approvals for the

developed products and sales volume;

(ii) make certain milestone payments up to a total of $156 million, including payments

associated with the successful product development and attainment of certain U.S.

and EU regulatory approvals for the developed products

and sales volume;

and (iii) pay royalties on net sales of the products.

can terminate the Collaboration Agreement at any time prior to the first commercial sale of the first product developed under

the Collaboration Agreement, in its sole discretion, without cause.

Furthermore, research collaborations, including the Collaboration

Agreement, may turn out to be unsuccessful and are subject to certain risks, including the following risks:

disagreements

with Merck resulting in delays or termination of the research, development or commercialization of product candidates, or

the focus by Merck of its development and commercialization efforts;

by Merck to commit sufficient resources to the testing, marketing, distribution or development of product candidates;

by Merck of alternative products either on its own or in collaboration with others, or conflicts of interest or changes in

business strategy or other business issues, which could adversely affect its willingness or ability to fulfill their obligations

our collaboration with Merck is unsuccessful for these or other reasons, or is otherwise terminated for any reason, we would not

receive the milestone payments or royalties under the Collaboration Agreement.

pursuant to the Collaboration Agreement Merck will only be obligated to make many of the milestone payments if our influenza A/B

product receives required regulatory approvals, is commercialized and net sales exceed the thresholds set forth in the Collaboration

can terminate the Collaboration Agreement at any time prior to the first commercial sale of the first product developed under the Collaboration

Agreement, in its sole discretion, without cause.

Furthermore, research collaborations, including the Collaboration Agreement, may turn

out to be unsuccessful and are subject to certain risks, including the following risks:

disagreements with Merck

resulting in delays or termination of the research, development or commercialization of product candidates, or litigation;

change the focus by Merck

of its development and commercialization efforts;

failure by Merck to commit

sufficient resources to the testing, marketing, distribution or development of product candidates;

development by Merck of

alternative products either on its own or in collaboration with others, or conflicts of interest or changes in business strategy

or other business issues, which could adversely affect its willingness or ability to fulfill their obligations to us.

our collaboration with Merck is unsuccessful for these or other reasons, or is otherwise terminated for any reason, we would not receive

the milestone payments or royalties under the Collaboration Agreement.

pursuant to the Collaboration Agreement Merck will only be obligated to make many of the milestone payments if our Influenza A/B product

receives required regulatory approvals, is commercialized and net sales exceed the thresholds set forth in the Collaboration Agreement.

Achieving the milestones may be difficult and time-consuming.

If some or all of these goals are not achieved, we may

not receive some or all of the milestone payments under the Collaboration Agreement.

If some or all of these goals are not achieved, we may not receive some

or all of the milestone payments under the Collaboration Agreement.

As of the date of this Report, none of the milestones under the Collaboration

Agreement have been reached.

of the foregoing could have a material adverse effect on our ability to successfully develop and commercialize Influenza A/B product

candidates and our future financial condition.

we form strategic alliances which are unsuccessful or are terminated, we may be unable to develop or commercialize certain product

candidates and we may be unable to generate revenues from our development programs.

addition to the Collaboration Agreement with Merck, we are likely to use third-party alliance partners for financial, scientific,

manufacturing, marketing and sales resources for the clinical development and commercialization of certain of our product candidates.

These strategic alliances will likely constrain our control over development and commercialization of our product candidates,

especially once a candidate has reached the stage of clinical development.

Our ability to recognize revenues from successful strategic

alliances may be impaired by several factors including:

partner may shift its priorities and resources away from our programs due to a change in business strategies, or a merger,

acquisition, sale or downsizing of its company or business unit;

partner may cease development in therapeutic areas which are the subject of our strategic alliances;

partner may change the success criteria for a program or product candidate delaying or ceasing development of such program

or candidate;

significant delay in initiation of certain development activities by a partner could also delay payment of milestones tied

to such activities, impacting our ability to fund our own activities;

partner could develop a product that competes, either directly or indirectly, with an alliance product;

partner with commercialization obligations may not commit sufficient financial or human resources to the marketing, distribution

or sale of a product;

partner with manufacturing responsibilities may encounter regulatory, resource or quality issues and be unable to meet demand

requirements;

partner may exercise its rights under the agreement to terminate a strategic alliance, including termination without cause;

dispute may arise between us and a partner concerning the research, development or commercialization of a program or product

candidate resulting in a delay in milestones, royalty payments or termination of a program and possibly resulting in costly

litigation or arbitration which may divert management attention and resources;

partner may use our proprietary information or intellectual property to invite litigation from a third-party or fail to maintain

or prosecute intellectual property rights possibly jeopardizing our rights in such property.

we form strategic alliances which are unsuccessful or are terminated, we may be unable to develop or commercialize certain product candidates

and we may be unable to generate revenues from our development programs.

addition to the Collaboration Agreement with Merck, we are likely to use third-party alliance partners for financial, scientific, manufacturing,

marketing and sales resources for the clinical development and commercialization of certain of our product candidates.

These strategic

alliances will likely constrain our control over development and commercialization of our product candidates, especially once a candidate

has reached the stage of clinical development.

Our ability to recognize revenues from successful strategic alliances may be impaired

by several factors including:

a partner may shift its

priorities and resources away from our programs due to a change in business strategies, or a merger, acquisition, sale or downsizing

of its company or business unit;

a partner may cease development

in therapeutic areas which are the subject of our strategic alliances;

a partner may change the

success criteria for a program or product candidate delaying or ceasing development of such program or candidate;

a significant delay in

initiation of certain development activities by a partner could also delay payment of milestones tied to such activities, impacting

our ability to fund our own activities;

a partner could develop

a product that competes, either directly or indirectly, with an alliance product;

a partner with commercialization

obligations may not commit sufficient financial or human resources to the marketing, distribution or sale of a product;

a partner with manufacturing

responsibilities may encounter regulatory, resource or quality issues and be unable to meet demand requirements;

a partner may exercise

its rights under the agreement to terminate a strategic alliance, including termination without cause;

a dispute may arise between

us and a partner concerning the research, development or commercialization of a program or product candidate resulting in a delay

in milestones, royalty payments or termination of a program and possibly resulting in costly litigation or arbitration which may

divert management attention and resources;

a partner may use our proprietary

information or intellectual property to invite litigation from a third-party or fail to maintain or prosecute intellectual property

rights possibly jeopardizing our rights in such property.

of a strategic alliance may require us to seek out and establish alternative strategic alliances with third-party partners.

may not be possible, including due to restrictions under the terms of our existing collaborations, or we may not be able to do

so on terms acceptable to us.

See also the risk factor entitled “We will depend on Merck for the successful research, development

and commercialization of our influenza A/B product candidates.”

If we fail to establish alternative strategic alliances

with third-party partners on terms acceptable to us, or at all, we may be required to limit the size or scope of one or more of

our programs or decrease our expenditures and seek additional funding by other means.

Such events would likely have a material

adverse effect on our results of operations and financial condition.

expect to rely on third parties to conduct some or all aspects of our compound formulation, research and preclinical testing,

if those third parties do not perform satisfactorily our business and future prospects would be materially and adversely affected.

do not expect to independently conduct all aspects of our drug discovery activities, compound formulation research or preclinical

testing of product candidates.

We rely and expect to continue to rely on third parties to conduct some aspects of our preclinical

testing and on third-party Clinical Research Organizations (“CROs”) to conduct clinical trials.

these third parties terminate their engagements, we will need to enter into alternative arrangements which would delay our product

development activities.

Our reliance on these third parties for research and development activities will reduce our control over

these activities but will not relieve us of our responsibilities.

If in the future, we elect to develop and commercialize any

product candidates on our own, we will remain responsible for ensuring that each of our IND-enabling preclinical studies and clinical

trials are conducted under the respective study plans and trial protocols.

If these third parties do not successfully carry out

their contractual duties, meet expected deadlines or conduct our studies under regulatory requirements or our stated study plans

and protocols, we will not be able to complete, or may experience delays in completing, the necessary clinical trials and preclinical

studies to enable us or our partners to select viable product candidates for IND submissions and will not be able to, or may be

delayed in our efforts to, successfully develop and commercialize such product candidates.

we intend to rely on third-party manufacturers to produce our preclinical and clinical supplies, and commercial supplies of any

approved product candidates, we will be subject to a variety of risks.

reliance on third-party manufacturers to develop products and our anticipated reliance on third-party manufacturers to produce

products we may develop in the future entail risks to which we would not be subject if we supplied the materials needed to develop

and manufacture our product candidates ourselves, including:

inability to meet any product specifications and quality requirements consistently;

delay or inability to procure or expand sufficient manufacturing capacity;

discontinuation

or recall of reagents, test kits, instruments, and other items used by us in the development, testing, and potential commercialization

manufacturing

and product quality issues related to scale-up of manufacturing;

and validation of new equipment and facilities required for scale-up;

failure to comply with cGMP and similar foreign standards;

inability to negotiate manufacturing agreements with third parties under commercially reasonable terms;

possibility of breach or termination or nonrenewal of manufacturing agreements with third parties in a manner that is costly

or damaging to us;

reliance on a few sources, and sometimes, single sources for raw materials, such that if we cannot secure a sufficient supply

of these product components, we cannot manufacture and sell product candidates in a timely fashion, in sufficient quantities

or under acceptable terms;

lack of qualified backup suppliers for any raw materials currently purchased from a single source supplier;

of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including

the bankruptcy of the manufacturer or supplier;

disruptions or increased costs beyond our control;

misappropriation

of our proprietary technology for the purpose of manufacturing a “generic”

version of our product or sale of our

product to organizations that distribute and sell counterfeit goods, including drugs;

to deliver products under specified storage conditions and in a timely manner.

not be possible, including due to restrictions under the terms of our existing collaborations, or we may not be able to do so on terms

acceptable to us.

See also the risk factor entitled “We will depend on Merck for the successful research, development and commercialization

of our Influenza A/B product candidates.” If we fail to establish alternative strategic alliances with third-party partners on

terms acceptable to us, or at all, we may be required to limit the size or scope of one or more of our programs or decrease our expenditures

and seek additional funding by other means.

Such events would likely have a material adverse effect on our results of operations and

financial condition.

expect to rely on third parties to conduct some or all aspects of our compound formulation, research and preclinical testing, if those

third parties do not perform satisfactorily our business and future prospects would be materially and adversely affected.

do not expect to independently conduct all aspects of our drug discovery activities, compound formulation research or preclinical testing

of product candidates.

We rely and expect to continue to rely on third parties to conduct some aspects of our preclinical testing and

on third-party CROs to conduct clinical trials.

This reliance can materially delay our research and developments efforts, and increase

the costs of undertaking them.

For example, beginning in 2021, certain of our CROs began experiencing staffing shortages and other issues

due to the outbreak of Omicron cases, resulting in delays and increased costs in researching our product candidates.

We have also experienced

material delays and cost increases in general throughout the pandemic caused by pandemic-related difficulties faced by our CROs and CMOs.

See the risk factor titled “Our business has been and may continue to be affected by the COVID-19 pandemic, and the full extent

of such impact remains uncertain.” Further, any disputes that may arise from our arrangements with CROs or CMOs may result in additional

unexpected expenses and force our management to allocate their limited time to seeking a resolution to the problem, which could materially

adversely affect our operations.

these third parties terminate their engagements, we will need to enter into alternative arrangements which would delay our product development

Our reliance on these third parties for research and development activities will reduce our control over these activities

but will not relieve us of our responsibilities.

If in the future, we elect to develop and commercialize any product candidates on our

own, we will remain responsible for ensuring that each of our IND-enabling preclinical studies and clinical trials are conducted under

the respective study plans and trial protocols.

If these third parties do not successfully carry out their contractual duties, meet expected

deadlines or conduct our studies under regulatory requirements or our stated study plans and protocols, we will not be able to complete,

or may experience delays in completing, the necessary clinical trials and preclinical studies to enable us or our partners to select

viable product candidates for IND submissions and will not be able to, or may be delayed in our efforts to, successfully develop and

commercialize such product candidates.

we intend to rely on third-party manufacturers to produce our preclinical and clinical supplies, and commercial supplies of any approved

product candidates, we will be subject to a variety of risks.

reliance on third-party manufacturers to develop products and our anticipated reliance on third-party manufacturers to produce products

we may develop in the future entail risks to which we would not be subject if we supplied the materials needed to develop and manufacture

our product candidates ourselves, including:

the ongoing supply chain

the inability to meet any

product specifications and quality requirements consistently;

a delay or inability to

procure or expand sufficient manufacturing capacity;

discontinuation or recall

of reagents, test kits, instruments, and other items used by us in the development, testing, and potential commercialization of products;

manufacturing and product

quality issues related to scale-up of manufacturing;

costs and validation of

new equipment and facilities required for scale-up;

a failure to comply with

cGMP and similar foreign standards;

the inability to negotiate

manufacturing agreements with third parties under commercially reasonable terms;

the possibility of breach

or termination or nonrenewal of manufacturing agreements with third parties in a manner that is costly or damaging to us;

the reliance on a few sources,

and sometimes, single sources for raw materials, such that if we cannot secure a sufficient supply of these product components, we

cannot manufacture and sell product candidates in a timely fashion, in sufficient quantities or under acceptable terms;

the lack of qualified backup

suppliers for any raw materials currently purchased from a single source supplier;

operations of our third-party

manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including the bankruptcy of

the manufacturer or supplier;

carrier disruptions or

increased costs beyond our control;

misappropriation of our

proprietary technology for the purpose of manufacturing a “generic” version of our product or sale of our product to

organizations that distribute and sell counterfeit goods, including drugs;

failing to deliver products

under specified storage conditions and in a timely manner.

events could lead to clinical study delays or failure to obtain regulatory approval or impact our ability to successfully commercialize

future products.

Some of these events could be the basis for regulatory actions, including injunction, recall, seizure or total

or partial suspension of production.

we expect to rely on limited sources of supply for the drug substance and drug product of product candidates, any disruption in

the chain of supply may cause a delay in developing and commercializing these product candidates.

Some of these events could be the basis for regulatory actions, including injunction, recall, seizure or total or partial

suspension of production.

we expect to rely on limited sources of supply for the drug substance and drug product of product candidates, any disruption in the chain

of supply may cause a delay in developing and commercializing these product candidates.

intend to establish manufacturing relationships with a limited number of suppliers to manufacture raw materials, the drug substance,

and the drug product of any product candidate for which we are responsible for preclinical or clinical development.

Each supplier

may require licenses to manufacture such components if such processes are not owned by the supplier or in the public domain.

part of any marketing approval, a manufacturer and its processes must be qualified by the FDA or foreign regulatory authorities

prior to commercialization.

If supply from the approved vendor is interrupted, there could be a significant disruption in commercial

An alternative vendor would need to be qualified through an NDA or marketing authorization supplement, which could cause

Each supplier may

require licenses to manufacture such components if such processes are not owned by the supplier or in the public domain.

As part of any

marketing approval, a manufacturer and its processes must be qualified by the FDA or foreign regulatory authorities prior to commercialization.

If supply from the approved vendor is interrupted, there could be a significant disruption in commercial supply.

An alternative vendor

would need to be qualified through a New Drug Application (“NDA”) or marketing authorization supplement, which could cause

further delay.

The FDA or other regulatory agencies outside of the United States may also require additional studies if a new

supplier is relied upon for commercial production.

factors could cause the delay of clinical trials, regulatory submissions, required approvals or commercialization of our product

candidates, cause us to incur higher costs and prevent us from commercializing our products successfully.

Furthermore, if our

suppliers fail to deliver the required commercial quantities of drug substance or drug product on a timely basis and at commercially

reasonable prices, and we are unable to secure one or more replacement suppliers capable of production at a substantially equivalent

cost, our clinical trials may be delayed, or we could lose potential revenue.

The FDA or other regulatory agencies outside of the United States may also require additional studies if a new supplier

is relied upon for commercial production.

factors could cause the delay of clinical trials, regulatory submissions, required approvals or commercialization of our product candidates,

cause us to incur higher costs and prevent us from commercializing our products successfully.

Furthermore, if our suppliers fail to deliver

the required commercial quantities of drug substance or drug product on a timely basis and at commercially reasonable prices, and we

are unable to secure one or more replacement suppliers capable of production at a substantially equivalent cost, our clinical trials

may be delayed, or we could lose potential revenue.

third party manufacturing issues arise, it could increase product and regulatory approval costs or delay commercialization.

third parties scale up manufacturing of product candidates and conduct required stability testing, product, packaging, equipment

and process-related issues may require refinement or resolution to proceed with any clinical trials and obtain regulatory approval

for commercial marketing.

We or the manufacturers may identify significant impurities or stability problems, which could cause

discontinuation or recall by us or our manufacturers, increased scrutiny by regulatory agencies, delays in clinical programs and

regulatory approval, significant increases in our operating expenses, or failure to obtain or maintain approval for product candidates

or any approved products.

we expect to continue to rely on third parties to conduct, supervise and monitor our clinical trials, if those third parties perform

in an unsatisfactory manner it may harm our business.

third parties scale up manufacturing of product candidates and conduct required stability testing, product, packaging, equipment and

process-related issues may require refinement or resolution to proceed with any clinical trials and obtain regulatory approval for commercial

We or the manufacturers may identify significant impurities or stability problems, which could cause discontinuation or recall

by us or our manufacturers, increased scrutiny by regulatory agencies, delays in clinical programs and regulatory approval, significant

increases in our operating expenses, or failure to obtain or maintain approval for product candidates or any approved products.

we expect to continue to rely on third parties to conduct, supervise and monitor our clinical trials, if those third parties fail to

perform in a satisfactory manner and one that meets applicable regulatory, scientific and safety requirements, it may materially harm

our business.

will rely on CROs and clinical trial sites to ensure the proper and timely conduct of our clinical trials.

While we establish

agreements governing the activities of such CROs and clinical trial sites, we or our partners will have limited influence over

their actual performance.

Nevertheless, we or our partners will be responsible for ensuring that each of our clinical trials is

conducted in accordance with its protocol, and that all legal, regulatory and scientific standards are met.

Our reliance on the

CROs does not relieve us of our regulatory responsibilities.

our partners and our CROs must comply with current Good Clinical Practices (“cGCPs”), as defined by the FDA and the

International Conference on Harmonization, for conducting, recording and reporting the results of IND-enabling preclinical studies

and clinical trials, to ensure that data and reported results are credible and accurate and that the rights, integrity and confidentiality

of clinical trial participants are protected.

The FDA enforces these cGCPs through periodic inspections of trial sponsors, principal

investigators, and clinical trial sites.

If we or our CROs fail to comply with cGCPs, the clinical data generated in our clinical

trials may be deemed unreliable and the FDA or other regulators may require us to perform additional clinical trials before approving

any marketing applications.

Our clinical trials will require a sufficiently large number of test subjects to evaluate the safety

and effectiveness of a product candidate.

If our CROs fail to comply with these regulations or fail to recruit a sufficient number

of patients, fail to recruit properly qualified patients or fail to properly record or maintain patient data, we may be required

to repeat such clinical trials, which would delay the regulatory approval process.

contracted CROs will not be our employees, and we cannot control whether they devote sufficient time and resources to our clinical

and nonclinical programs.

These CROs may also have relationships with other commercial entities, including our competitors, for

whom they may also be conducting clinical trials, or other drug development activities that could harm our competitive position.

If our CROs do not successfully carry out their contractual duties or obligations, fail to meet expected deadlines, or if the

quality or accuracy of the clinical data they obtain is compromised due to failing to adhere to our clinical protocols or regulatory

requirements, or for any other reasons, our clinical trials may be extended, delayed or terminated, and we may not obtain regulatory

approval for, or successfully commercialize our product candidates.

Our financial results and the commercial prospects for such

products and any product candidates we develop would be harmed, our costs could increase, and our ability to generate revenues

could be delayed.

While we establish agreements

governing the activities of such CROs and clinical trial sites, we or our partners will have limited influence over their actual performance.

Nevertheless, we or our partners will be responsible for ensuring that each of our clinical trials is conducted in accordance with its

protocol, and that all legal, regulatory and scientific standards are met.

Our reliance on the CROs does not relieve us of our regulatory

responsibilities.

our partners and our CROs must comply with current Good Clinical Practices (“cGCPs”), as defined by the FDA and the International

Conference on Harmonization, for conducting, recording and reporting the results of IND-enabling preclinical studies and clinical trials,

to ensure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of clinical trial

participants are protected.

The FDA enforces these cGCPs through periodic inspections of trial sponsors, principal investigators, and

clinical trial sites.

If we or our CROs fail to comply with cGCPs, the clinical data generated in our clinical trials may be deemed unreliable

and the FDA or other regulators may require us to perform additional clinical trials before approving any marketing applications.

clinical trials will require a sufficiently large number of test subjects to evaluate the safety and effectiveness of a product candidate.

If our CROs fail to comply with these regulations or fail to recruit a sufficient number of patients, fail to recruit properly qualified

patients or fail to properly record or maintain patient data, we may be required to repeat such clinical trials, which would delay the

regulatory approval process.

contracted CROs will not be our employees, and we cannot control whether they devote sufficient time and resources to our clinical and

nonclinical programs.

These CROs may also have relationships with other commercial entities, including our competitors, for whom they

may also be conducting clinical trials, or other drug development activities that could harm our competitive position.

If our CROs do

not successfully carry out their contractual duties or obligations, fail to meet expected deadlines, or if the quality or accuracy of

the clinical data they obtain is compromised due to failing to adhere to our clinical protocols or regulatory requirements, or for any

other reasons, our clinical trials may be extended, delayed or terminated, and we may not obtain regulatory approval for, or successfully

commercialize our product candidates.

Our financial results and the commercial prospects for such products and any product candidates

we develop would be harmed, our costs could increase, and our ability to generate revenues could be delayed.

also expect to rely on other third parties to store and distribute drug products for any clinical trials we may conduct.

Any performance

failure by our distributors could delay clinical development or marketing approval of our product candidates or commercialization

of our products, if approved, producing additional losses and depriving us of potential product revenue.

failure by our distributors could delay clinical development or marketing approval of our product candidates or commercialization of

our products, if approved, producing additional losses and depriving us of potential product revenue.

the approach we are taking to discover and develop drugs is novel, it may never lead to marketable products.

are concentrating our antiviral therapeutic product research and development efforts on using our proprietary technology, and

our future success depends on the continued successful development of this technology and the products derived from it.

never commercialized any products.

The scientific discoveries that form the basis for our efforts to discover and develop drug

product candidates are relatively new and unproven.

The scientific evidence to support the feasibility of developing product candidates

based on our approach is limited.

If we do not successfully develop and commercialize drug product candidates based upon our technological

approach, we may not become profitable and the value of our stock may decline.

our focus on the Company’s technology for developing drugs, as opposed to relying entirely on more standard technologies

for drug development, increases the risks associated with the ownership of our stock.

If we are unsuccessful in developing any

product candidates using the Company’s technology, we may be required to change the scope and direction of our product development

We may not successfully identify and implement an alternative product development strategy and may as a result cease

are concentrating our antiviral therapeutic product research and development efforts on using our proprietary technology, and our future

success depends on the continued successful development of this technology and the products derived from it.

We have never commercialized

any products.

The scientific discoveries that form the basis for our efforts to discover and develop drug product candidates are relatively

new and unproven.

The scientific evidence to support the feasibility of developing product candidates based on our approach is limited.

If we do not successfully develop and commercialize drug product candidates based upon our technological approach, we may not become

profitable and the value of our stock may decline.

our focus on the Company’s technology for developing drugs, as opposed to relying entirely on more standard technologies for drug

development, increases the risks associated with the ownership of our stock.

If we are unsuccessful in developing any product candidates

using the Company’s technology, we may be required to change the scope and direction of our product development activities.

may not successfully identify and implement an alternative product development strategy and may as a result cease operations.

we do not succeed in our efforts to identify or discover additional potential product candidates, your investment may be lost.

success of our business depends primarily upon our ability to identify, develop and commercialize antiviral drug products, an

extremely risky business.

Our research programs may initially show promise in identifying potential product candidates, yet fail

to yield product candidates for clinical development for several reasons, including:

research methodology or that of our partners may be unsuccessful in identifying potential product candidates;

product candidates may have harmful side effects or may have other characteristics that make the products unmarketable or

unlikely to receive marketing approval;

or our partners may change their development profiles for potential product candidates or abandon a therapeutic area.

events may force us to abandon our development efforts for a program or programs, which would have a material adverse effect on

our business and could cause us to cease operations.

Research programs to identify new product candidates require substantial

technical, financial, and human resources.

We may focus our efforts and resources on potential programs or product candidates

that ultimately prove to be unsuccessful.

our future commercial success depends on gaining regulatory approval for our products, we cannot generate revenue without obtaining

long-term success and generation of revenue will depend upon the successful development of new products from our research and

development activities, including those licensed or acquired from third parties.

Product development is very expensive and involves

a high degree of risk.

success of our business depends primarily upon our ability to identify, develop and commercialize antiviral drug products, an extremely

risky business.

Our research programs may initially show promise in identifying potential product candidates, yet fail to yield product

candidates for clinical development for several reasons, including:

our research methodology

or that of our partners may be unsuccessful in identifying potential product candidates;

potential product candidates

may have harmful side effects or may have other characteristics that make the products unmarketable or unlikely to receive marketing

we or our partners may

change their development profiles for potential product candidates or abandon a therapeutic area.

events may force us to abandon our development efforts for a program or programs, which would have a material adverse effect on our business

and could cause us to cease operations.

Research programs to identify new product candidates require substantial technical, financial,

and human resources.

We may focus our efforts and resources on potential programs or product candidates that ultimately prove to be unsuccessful.

our future commercial success depends on gaining regulatory approval for our products, we cannot generate revenue without obtaining approvals .

long-term success and generation of revenue will depend upon the successful development of new products from our research and development

activities, including those licensed or acquired from third parties.

Product development is very expensive and involves a high degree

Only a small number of research and development programs result in the commercialization of a product.

The process for obtaining regulatory approval to market product candidates is expensive, usually takes many years, and can vary

substantially based on the type, complexity, and novelty of the product candidates involved.

Our ability to generate revenues

would be adversely affected if we are delayed or unable to successfully develop our products.

For example, the FDA

indicates that approximately 70% of drugs proceed past Phase 1 studies, 33% proceed past Phase 2, and just 25%-30% proceed past Phase

3 to Phase 4 which is the final phase in the FDA review and approval process for marketing therapeutic product candidates.

for obtaining regulatory approval to market product candidates is expensive, usually takes many years, and can vary substantially based

on the type, complexity, and novelty of the product candidates involved.

Our ability to generate revenues would be adversely affected

if we are delayed or unable to successfully develop our products.

cannot guarantee that any marketing application for our product candidates will be approved.

2 unchanged sentences

curtail operations.

we are unable to successfully complete preclinical testing and clinical trials of our product candidates or experience significant

delays in doing so, our business will be materially harmed.

intend to invest a significant portion of our efforts and financial resources in the identification and preclinical development

of product candidates that target viral replication enzymes.

Our ability to generate product revenues, which we do not expect

will occur for many years, if ever, will depend heavily on the successful development and eventual commercialization of our product

we are unable to successfully complete preclinical testing and clinical trials of our product candidates or experience significant delays

in doing so, our business will be materially harmed.

intend to invest a significant portion of our efforts and financial resources in the identification and preclinical development of product

candidates that target viral replication enzymes.

Our ability to generate product revenues, which we do not expect will occur for many

years, if ever, will depend heavily on the successful development and eventual commercialization of our product candidates.

commercial success of our product candidates will depend on several factors, including:

completion of preclinical studies and clinical trials;

of marketing and pricing approvals from regulatory authorities;

and maintaining patent and trade secret protection for product candidates;

and maintaining manufacturing relationships with third parties or establishing our own manufacturing capability;

commercializing

our products, if and when approved, whether alone or in collaboration with others.

we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability

to successfully complete development of, or to successfully commercialize, our product candidates, which would materially harm

our business.

Most pharmaceutical products that do overcome the long odds of drug development and achieve commercialization still

do not recoup their cost of capital.

If we are unable to design and develop each drug to meet a commercial need far in the future,

the approved drug may become a commercial failure and our investment in those development and commercialization efforts will have

been commercially unsuccessful.

may be unable to demonstrate safety and efficacy of our product candidates to the satisfaction of regulatory authorities or we

may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization

of our product candidates.

successful completion of

preclinical studies and clinical trials;

receipt of marketing and

pricing approvals from regulatory authorities;

obtaining and maintaining

patent and trade secret protection for product candidates;

establishing and maintaining

manufacturing relationships with third parties or establishing our own manufacturing capability;

commercializing our products,

if and when approved, whether alone or in collaboration with others.

we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to

successfully complete development of, or to successfully commercialize, our product candidates, which would materially harm our business.

Most pharmaceutical products that do overcome the long odds of drug development and achieve commercialization still do not recoup their

cost of capital.

If we are unable to design and develop each drug to meet a commercial need far in the future, the approved drug may

become a commercial failure and our investment in those development and commercialization efforts will have been commercially unsuccessful.

may be unable to demonstrate safety and efficacy of our product candidates to the satisfaction of regulatory authorities or we may incur

additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our

product candidates.

obtaining marketing approval from regulatory authorities for the sale of product candidates, we or our partners must conduct extensive

preclinical studies and clinical trials to demonstrate the safety and efficacy of the product candidates in humans.

Clinical trials

are expensive, difficult to design and implement, can take many years to complete and are uncertain as to outcome.

one or more clinical trials can occur at any stage of testing.

The outcome of preclinical studies and early clinical trials may

not be predictive of the success of later clinical trials, and interim results of a clinical trial do not predict final results.

Moreover, preclinical, and clinical data are often susceptible to varying interpretations and analyses, and many companies that

have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed

to obtain marketing approval for their products.

Clinical trials are

expensive, difficult to design and implement, can take many years to complete and are uncertain as to outcome.

A failure of one or more

clinical trials can occur at any stage of testing.

The outcome of preclinical studies and early clinical trials may not be predictive

of the success of later clinical trials, and interim results of a clinical trial do not predict final results.

Moreover, preclinical,

and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product

candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval for

their products.

that may cause a delay or unsuccessful completion of clinical development include, among other things:

in agreeing with the FDA or other regulatory authorities on final clinical trial design;

of a clinical hold following an inspection of our clinical trial operations or trial sites by the FDA or other regulatory

in agreeing on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites;

in obtaining required institutional review board approval at each clinical trial site;

in recruiting suitable patients to participate in a trial;

in the testing, validation, manufacturing and delivery of the product candidates to the clinical sites;

in having patients complete participation in a trial or return for post-treatment follow-up;

caused by patients dropping out of a trial due to product side effects or disease progression;

sites dropping out of a trial to the detriment of enrollment;

or inconclusive results of clinical trials of our product candidates;

and expenses required to add new clinical sites;

by our contract manufacturers in producing and delivering sufficient supply of clinical trial materials.

delays in agreeing with

the FDA or other regulatory authorities on final clinical trial design;

imposition of a clinical

hold following an inspection of our clinical trial operations or trial sites by the FDA or other regulatory authorities;

delays in agreeing on acceptable

terms with prospective contract research organizations, or CROs, and clinical trial sites;

delays in obtaining required

institutional review board approval at each clinical trial site;

delays in recruiting suitable

patients to participate in a trial;

delays in the testing,

validation, manufacturing and delivery of the product candidates to the clinical sites;

delays in having patients

complete participation in a trial or return for post-treatment follow-up;

delays caused by patients

dropping out of a trial due to product side effects or disease progression;

clinical sites dropping

out of a trial to the detriment of enrollment;

negative or inconclusive

results of clinical trials of our product candidates;

time and expenses required

to add new clinical sites;

delays by our contract

manufacturers in producing and delivering sufficient supply of clinical trial materials.

we or our partners must conduct additional clinical trials or other testing of any product candidates beyond those that are contemplated,

or are unable to successfully complete clinical trials or other testing of any of our product candidates, or if the results of

these trials or tests are not positive or are only modestly positive or if there are safety concerns, we or our partners may:

delayed in obtaining marketing approval for our product candidates;

obtain marketing approval at all;

approval for indications or patient populations not as broad as intended or desired;

approval with labeling that includes significant use or distribution restrictions or safety warnings;

subject to additional post-marketing testing requirements;

the product from the market after obtaining marketing approval.

or are unable to successfully complete clinical trials or other testing of any of our product candidates, or if the results of these

trials or tests are not positive or are only modestly positive or if there are safety concerns, we or our partners may:

be delayed in obtaining

marketing approval for our product candidates;

not obtain marketing approval

obtain approval for indications

or patient populations not as broad as intended or desired;

obtain approval with labeling

that includes significant use or distribution restrictions or safety warnings;

be subject to additional

post-marketing testing requirements;

remove the product from

the market after obtaining marketing approval.

product development costs will also increase if we experience delays in testing or in obtaining marketing approvals.

know whether any clinical trials will begin as planned, will need to be restructured or will be completed on schedule, if at all.

Significant clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize

our product candidates or allow our competitors to bring products to market before we do, which would impair our ability to successfully

commercialize our product candidates and may harm our business and results of operations.

Any inability to successfully complete

preclinical and clinical development, whether independently or with our partners, could cause additional costs to us or impair

our ability to generate revenues from our product candidates, including product sales, milestone payments, profit sharing or royalties.

product candidates may cause adverse effects or have other properties that could delay or prevent their regulatory approval or

limit the scope of any approved label or market acceptance.

events (“AEs”) or serious adverse events (“SAEs”), that may be observed during clinical trials of our

product candidates could cause us, other reviewing entities, clinical trial sites or regulatory authorities to interrupt, delay

or halt such trials and could cause denial of regulatory approval.

If AEs or SAEs are observed in any clinical trials of our product

candidates, including those our partners may develop under alliance agreements, our or our partners’

ability to obtain regulatory

approval for product candidates may be negatively impacted.

We do not know whether

any clinical trials will begin as planned, will need to be restructured or will be completed on schedule, if at all.

Significant clinical

trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow

our competitors to bring products to market before we do, which would impair our ability to successfully commercialize our product candidates

and may harm our business and results of operations.

Any inability to successfully complete preclinical and clinical development, whether

independently or with our partners, could cause additional costs to us or impair our ability to generate revenues from our product candidates,

including product sales, milestone payments, profit sharing or royalties.

product candidates may cause adverse effects or have other properties that could delay or prevent their regulatory approval or limit

the scope of any approved label or market acceptance.

events (“AEs”) or serious adverse events (“SAEs”), that may be observed during clinical trials of our product

candidates could cause us, other reviewing entities, clinical trial sites or regulatory authorities to interrupt, delay or halt such

trials and could cause denial of regulatory approval.

If AEs or SAEs are observed in any clinical trials of our product candidates, including

those our partners may develop under alliance agreements, our or our partners’ ability to obtain regulatory approval for product

candidates may be negatively impacted.

or unexpected side effects caused by an approved product could result in significant negative consequences, including the following:

authorities may withdraw prior approval of the product or impose restrictions on its distribution in the form of a modified

risk evaluation and

strategy (“REMS”) which may restrict the manner in which the product can be distributed or administered;

may be required to add labeling statements, such as warnings or contraindications;

may be required to change the way the product is administered or conduct additional clinical trials;

may decide or be forced to temporarily or permanently remove the affected product from the marketplace;

could be sued and held liable for harm caused to patients;

reputation may suffer.

authorities may withdraw prior approval of the product or impose restrictions on its distribution in the form of a modified risk

evaluation and mitigation strategy (“REMS”) which may restrict the manner in which the product can be distributed

or administered;

we may be required to add

labeling statements, such as warnings or contraindications;

we may be required to change

the way the product is administered or conduct additional clinical trials;

we may decide or be forced

to temporarily or permanently remove the affected product from the marketplace;

we could be sued and held

liable for harm caused to patients;

our reputation may suffer.

events could prevent us or our partners from achieving or maintaining market acceptance of the affected product and could substantially

increase the costs of commercializing our products and impair our ability to generate revenues from the commercialization of these

products either by us or by our partners.

regulatory approval for a product candidate, we will still face extensive regulatory requirements and the approved product may

face future development and regulatory difficulties.

increase the costs of commercializing our products and impair our ability to generate revenues from the commercialization of these products

either by us or by our partners.

regulatory approval for a product candidate, we will still face extensive regulatory requirements and the approved product may face future

development and regulatory difficulties.

if we obtain regulatory approval in the United States or elsewhere, the applicable regulators may still impose significant restrictions

on the indicated uses or marketing of our product candidates or impose ongoing requirements for potentially costly post-approval

studies or post-market surveillance.

on the indicated uses or marketing of our product candidates or impose ongoing requirements for potentially costly post-approval studies

or post-market surveillance.

The following discussion is based on United States law.

Similar types of regulatory provision

apply outside of the United States.

holder of an approved New Drug Application (“NDA”), must monitor and report AEs and SAEs and any failure of a product

to meet the specifications in the NDA.

The holder of an approved NDA must also submit new or supplemental applications and obtain

FDA approval for certain changes to the approved product, product labeling or manufacturing process.

Advertising and promotional

materials must comply with FDA rules and other applicable federal and state laws and are subject to FDA review.

product manufacturers and their facilities are subject to payment of user fees and continual review and periodic inspections by

the FDA and other regulatory authorities for compliance with current Good Manufacturing Practices (“cGMP”), and adherence

to commitments made in the NDA.

If we or a regulatory agency discover previously unknown problems with a product such as AEs or

SAEs of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency

may impose restrictions on that product or the manufacturing facility, including requiring recall or withdrawal of the product

from the market or suspension of manufacturing.

we or our partners fail to comply with regulatory requirements following approval of our product candidates, a regulatory agency

a warning letter asserting we are in violation of the law;

a REMS or other restrictions on the manufacturing, marketing or use of the product;

an injunction or impose civil or criminal penalties or monetary fines;

or withdraw regulatory approval;

any ongoing clinical trials;

to approve a pending NDA or supplements to an NDA submitted by us;

to allow us to enter into supply contracts, including government contracts.

defense of any government investigation of alleged violations of law, or any lawsuit alleging such violations, could require us

to expend significant time and resources and could generate negative publicity.

Further, the FDA’s and other regulatory

authorities’

policies may change, and additional government regulations may be enacted that could prevent, limit or delay

regulatory approval of our product candidates or increase the cost of compliance.

The occurrence of any event or penalty described

above may prevent or inhibit our ability to commercialize our products and generate revenues.

may not succeed in obtaining or maintaining necessary rights to drug compounds and processes for our development pipeline through

acquisitions and in-licenses.

may be unable to acquire or in-license any compositions, methods of use, processes, or other third-party intellectual property

rights from third parties we identify.

The licensing and acquisition of third-party intellectual property rights is a competitive

area, and more established companies are also pursuing strategies to license or acquire third-party intellectual property rights

we may consider attractive.

These established companies may have a competitive advantage over us due to their size, cash resources

and greater clinical development and commercialization capabilities.

Similar types of regulatory provision apply outside

of the United States.

holder of an approved NDA must monitor and report AEs and SAEs and any failure of a product to meet the specifications in the NDA.

holder of an approved NDA must also submit new or supplemental applications and obtain FDA approval for certain changes to the approved

product, product labeling or manufacturing process.

Advertising and promotional materials must comply with FDA rules and other applicable

federal and state laws and are subject to FDA review.

product manufacturers and their facilities are subject to payment of user fees and continual review and periodic inspections by the FDA

and other regulatory authorities for compliance with current Good Manufacturing Practices (“cGMP”), and adherence to commitments

made in the NDA.

If we or a regulatory agency discover previously unknown problems with a product such as AEs or SAEs of unanticipated

severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions on

that product or the manufacturing facility, including requiring recall or withdrawal of the product from the market or suspension of

manufacturing.

we or our partners fail to comply with regulatory requirements following approval of our product candidates, a regulatory agency may:

issue a warning letter

asserting we are in violation of the law;

impose a REMS or other

restrictions on the manufacturing, marketing or use of the product;

seek an injunction or impose

civil or criminal penalties or monetary fines;

suspend or withdraw regulatory

suspend any ongoing clinical

refuse to approve a pending

NDA or supplements to an NDA submitted by us;

seize product;

refuse to allow us to enter

into supply contracts, including government contracts.

defense of any government investigation of alleged violations of law, or any lawsuit alleging such violations, could require us to expend

significant time and resources and could generate negative publicity.

Further, the FDA’s and other regulatory authorities’

policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our

product candidates or increase the cost of compliance.

The occurrence of any event or penalty described above may prevent or inhibit

our ability to commercialize our products and generate revenues.

may not succeed in obtaining or maintaining necessary rights to drug compounds and processes for our development pipeline through acquisitions

and in-licenses.

may be unable to acquire or in-license any compositions, methods of use, processes, or other third-party intellectual property rights

from third parties we identify.

The licensing and acquisition of third-party intellectual property rights is a competitive area, and

more established companies are also pursuing strategies to license or acquire third-party intellectual property rights we may consider

These established companies may have a competitive advantage over us due to their size, cash resources and greater clinical

development and commercialization capabilities.

that perceive us to be a competitor may be unwilling to assign or license rights to us.

We also may be unable to license or acquire

third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment.

unable to successfully obtain rights to required third-party intellectual property rights, our business, financial condition,

and prospects for growth could suffer.

We also may be unable to license or acquire third-party

intellectual property rights on terms that would allow us to make an appropriate return on our investment.

If we are unable to successfully

obtain rights to required third-party intellectual property rights, our business, financial condition, and prospects for growth could

third parties may be developing competitive products without our knowledge, we may later learn that competitive products are superior

to our product candidates which may force us to terminate our research efforts of one or more product candidates.

face potential competition from companies, particularly privately-held companies and foreign companies that may be developing

competitive products that are superior to one or more of our product candidates.

If in the future, we learn of the existence of

one or more competitive products, we may be required to:

our development efforts for a product candidate;

a partner to terminate its support of a product candidate;

a potential partner to terminate discussions about a potential license.

of these events may occur after we have spent substantial sums in connection with the clinical research of one or more product

have limited experience in conducting and managing the preclinical development activities and clinical trials necessary to obtain

approvals for marketing our product candidates, including approval by the FDA.

face potential competition from companies, particularly privately-held companies and foreign companies that may be developing competitive

products that are superior to one or more of our product candidates.

If in the future, we learn of the existence of one or more competitive

products, we may be required to:

cease our development efforts

for a product candidate;

cause a partner to terminate

its support of a product candidate;

cause a potential partner

to terminate discussions about a potential license.

of these events may occur after we have spent substantial sums in connection with the clinical research of one or more product candidates.

have limited experience in conducting and managing the preclinical development activities and clinical trials necessary to obtain approvals

for marketing our product candidates, including approval by the FDA.

efforts to develop our product candidates are at an early stage.

To date, with one exception, we have not entered a compound into

human clinical trials, although we expect to initiate a Phase I trial for our Influenza A product candidate in the third quarter

To date, with two exceptions, including recently initiating a Phase

1 trial for our Influenza A product candidate in the first quarter of 2022, we have not entered other compounds into

human clinical trials,

We may be unable to progress our other product candidates undergoing preclinical testing into clinical trials.

in preclinical testing and early clinical trials does not ensure that later clinical trials will succeed, and favorable initial

results from a clinical trial do not determine outcomes in subsequent clinical trials.

The indications of use for which we are

pursuing development may have clinical effectiveness endpoints not previously reviewed or validated by the FDA or foreign regulatory

authorities, which may complicate or delay our effort to obtain marketing approval.

We cannot guarantee that our clinical trials

will succeed.

In fact, most compounds fail in clinical trials, even at companies far larger and more experienced than us.

Success in preclinical

testing and early clinical trials does not ensure that later clinical trials will succeed, and favorable initial results from a clinical

trial do not determine outcomes in subsequent clinical trials.

The indications of use for which we are pursuing development may have

clinical effectiveness endpoints not previously reviewed or validated by the FDA or foreign regulatory authorities, which may complicate

or delay our effort to obtain marketing approval.

We cannot guarantee that our clinical trials will succeed.

In fact, most compounds

fail in clinical trials, even at companies far larger and more experienced than us.

have not obtained marketing approval or commercialized any of our product candidates.

We may not successfully design or implement

clinical trials required for marketing approval to market our product candidates.

If we are unsuccessful in conducting and managing

our preclinical development activities or clinical trials or obtaining marketing approvals, we might not be able to commercialize

our product candidates, or might be significantly delayed in doing so, which will materially harm our business.

We may not successfully design or implement clinical

trials required for marketing approval to market our product candidates.

If we are unsuccessful in conducting and managing our preclinical

development activities or clinical trials or obtaining marketing approvals, we might not be able to commercialize our product candidates,

or might be significantly delayed in doing so, which will materially harm our business.

RELATED TO OUR BUSINESS OPERATIONS AND INDUSTRY

we cannot obtain or protect intellectual property rights related to our future products and product candidates, we may not be

able to compete effectively in our markets.

rely upon a combination of patents, trade secret protection and confidentiality agreements to protect the intellectual property

related to our future products and product candidates.

The strength of patents in the biotechnology and pharmaceutical field involves

complex legal and scientific questions and can be uncertain.

The patent applications we own or in-license may fail to result in

patents with claims that cover the products in the United States or in other countries.

There is no assurance that all potentially

relevant prior art relating to our patents and patent applications has been found;

such prior art can invalidate a patent or prevent

issuance of a patent based on a pending patent application.

Even if patents do successfully issue, third parties may challenge

their validity, enforceability or scope, which may cause such patents to be narrowed or invalidated.

Even if unchallenged, our

patents and patent applications may not adequately protect our intellectual property or prevent others from designing around our

the patent applications we hold or have in-licensed regarding our programs or product candidates fail to issue or if their breadth

or strength of protection is threatened, it could dissuade companies from collaborating with us to develop product candidates,

and threaten our ability to commercialize products.

Patents may not issue and issued patents may be found invalid and unenforceable

or challenged by third parties.

Since patent applications in the United States and most other countries are confidential for a

period after filing, and some remain so until issued, we cannot be certain that we were the first to invent a patent application

related to a product candidate.

In certain situations, if we and one or more third parties have filed patent applications in the

United States and claiming the same subject matter, an administrative proceeding can be initiated to determine which applicant

is entitled to the patent on that subject matter.

we cannot obtain or protect intellectual property rights related to our future products and product candidates, we may not be able to

compete effectively in our markets.

rely upon a combination of patents, trade secret protection and confidentiality agreements to protect the intellectual property related

to our future products and product candidates.

The strength of patents in the biotechnology and pharmaceutical field involves complex

legal and scientific questions and can be uncertain.

The patent applications we own or in-license may fail to result in patents with

claims that cover the products in the United States or in other countries.

There is no assurance that all potentially relevant prior

art relating to our patents and patent applications has been found;

such prior art can invalidate a patent or prevent issuance of a patent

based on a pending patent application.

Even if patents do successfully issue, third parties may challenge their validity, enforceability

or scope, which may cause such patents to be narrowed or invalidated.

Even if unchallenged, our patents and patent applications may not

adequately protect our intellectual property or prevent others from designing around our claims.

the patent applications we hold or have in-licensed regarding our programs or product candidates fail to issue or if their breadth or

strength of protection is threatened, it could dissuade companies from collaborating with us to develop product candidates, and threaten

our ability to commercialize products.

Patents may not issue and issued patents may be found invalid and unenforceable or challenged

by third parties.

Since patent applications in the United States and most other countries are confidential for a period after filing,

and some remain so until issued, we cannot be certain that we were the first to invent a patent application related to a product candidate.

In certain situations, if we and one or more third parties have filed patent applications in the United States and claiming the same

subject matter, an administrative proceeding can be initiated to determine which applicant is entitled to the patent on that subject

Patents have a limited lifespan.

In the United States, the natural expiration

of a patent is 20 years after it is filed, although various extensions may be available.

The life of a patent, and the protection

it affords, is limited.

When the patent life has expired for a product, we will become vulnerable to competition from generic

medications attempting to replicate that product.

Further, if we encounter delays in regulatory approvals, the time during which

we will be able to market and commercialize a product candidate under patent protection could be reduced.

addition to patent protection, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how

that is not patentable, processes for which patents are difficult to enforce and any other elements of our drug discovery and

development processes that involve proprietary know-how, information or technology not covered by patents.

Each of our employees

agrees to assign their inventions to us through an employee inventions agreement.

In addition, as a general practice, our employees,

consultants, advisors and any third parties who have access to our proprietary know-how, information or technology enter into

confidentiality agreements.

Nonetheless, our trade secrets and other confidential proprietary information may be disclosed and

competitors may otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques.

In addition, in January 2018 the FDA as part of its Transparency Initiative, launched a voluntary pilot program calling on biopharmaceutical

research companies to release clinical study reports summarizing clinical trial data.

Following the completion of this pilot program

in March 2020, the FDA may consider making release of clinical study reports mandatory and may consider making additional information

publicly available on a routine basis in response to concerns expressed by the academic community emphasized by the COVID-19 pandemic,

including information we may consider to be trade secrets or other proprietary information.

If the FDA takes these measures, we

may be forced to disclose propriety information about our product candidates and research, which could materially harm our business.

laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United

We may encounter significant problems in protecting and defending our intellectual property both in the United States

If we are unable to prevent material disclosure of the non-patented intellectual property related to our technologies

to third parties, and there is no guarantee we will have any such enforceable trade secret protection, we may not be able to establish

or maintain a competitive advantage in our market, which could materially adversely affect our business, results of operations

and financial condition.

In the United States, the natural expiration of a patent is 20 years after it is filed, although

various extensions may be available.

The life of a patent, and the protection it affords, is limited.

When the patent life has expired

for a product, we will become vulnerable to competition from generic medications attempting to replicate that product.

Further, if we

encounter delays in regulatory approvals, the time during which we will be able to market and commercialize a product candidate under

patent protection could be reduced.

addition to patent protection, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that

is not patentable, processes for which patents are difficult to enforce and any other elements of our drug discovery and development

processes that involve proprietary know-how, information or technology not covered by patents.

Each of our employees agrees to assign

their inventions to us through an employee inventions agreement.

In addition, as a general practice, our employees, consultants, advisors

and any third parties who have access to our proprietary know-how, information or technology enter into confidentiality agreements.

our trade secrets and other confidential proprietary information may be disclosed and competitors may otherwise gain access to our trade

secrets or independently develop substantially equivalent information and techniques.

In addition, in January 2018 the FDA as part of

its Transparency Initiative, launched a voluntary pilot program calling on biopharmaceutical research companies to release clinical study

reports summarizing clinical trial data.

Following the completion of this pilot program in March 2020, the FDA may consider making release

of clinical study reports mandatory and may consider making additional information publicly available on a routine basis in response

to concerns expressed by the academic community emphasized by the COVID-19 pandemic, including information we may consider to be trade

secrets or other proprietary information.

If the FDA takes these measures, we may be forced to disclose propriety information about our

product candidates and research, which could materially harm our business.

laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States.

We may encounter significant problems in protecting and defending our intellectual property both in the United States and abroad.

governments may in the future alter intellectual property rights in a manner adverse to us or to our third party collaborators, including

actions taken at the international level.

For example, a proposal has been advanced and is being considered by the World Trade Organization

beginning in late 2020, which is supported by multiple countries across the globe, including the U.S., which would implement a multi-jurisdictional

waiver of patent and other intellectual property rights with respect to vaccines and therapeutic products that target COVID-19 in an

effort to fight the pandemic and allow for a more equal distribution of resources towards that goal.

If the proposed waiver is implemented

or similar actions are taken with respect to COVID-19-related products or other products in which we are or may become involved, our

ability to protect the underlying intellectual property rights we rely on for such products, including those licensed from third parties,

could be materially diminished or eliminated, and as a result any potential competitive advantage would be lost.

If we are unable to

prevent material disclosure of the non-patented intellectual property related to our technologies to third parties, and there is no guarantee

we will have any such enforceable trade secret protection, we may not be able to establish or maintain a competitive advantage in our

market, which could materially adversely affect our business, results of operations and financial condition.

third-party intellectual property infringement claims are asserted against us, it may prevent or delay our development and commercialization

1 unchanged sentence

commercial success depends in part on our avoiding infringement on the patents and proprietary rights of third parties.

is substantial litigation, both within and outside the United States, involving patent and other intellectual property rights

in the biotechnology and pharmaceutical industries, including patent infringement lawsuits, interferences, oppositions, and reexaminations

and other post-grant proceedings before the U.S.

There is substantial

litigation, both within and outside the United States, involving patent and other intellectual property rights in the biotechnology and

pharmaceutical industries, including patent infringement lawsuits, interferences, oppositions, and reexaminations and other post-grant

proceedings before the U.S.

Patent and Trademark Office, and corresponding foreign patent offices.

and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which

we and our partners are pursuing product candidates.

As the biotechnology and pharmaceutical industries expand and more patents

are issued, the risk increases that our product candidates may be subject to claims of infringement of the patent rights of third

Numerous U.S.

and foreign issued patents

and pending patent applications, which are owned by third parties, exist in the fields in which we and our partners are pursuing product

As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our product

candidates may be subject to claims of infringement of the patent rights of third parties.

parties may assert that we are employing their proprietary technology without authorization.

There may be third-party patents

or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the

use or manufacture of our product candidates.

Because patent applications can take many years to issue, there may be patent applications

currently pending that may later result in patents that our product candidates may infringe upon.

Third parties may obtain patents

in the future and claim that use of our technologies infringes on these patents.

If any third-party patents were to be held by

a court of competent jurisdiction to cover the manufacturing process of any of our product candidates, any molecules formed during

the manufacturing process or any final product itself, the holders of any such patents may be able to block our ability to commercialize

such product candidate unless we obtained a license under the applicable patents, or until such patents expire.

Similarly, if

any third-party patents were to be held by a court of competent jurisdiction to cover aspects of our formulations, processes for

manufacture or methods of use, including combination therapy, the holders of any such patents may be able to block our ability

to develop and commercialize the applicable product candidate unless we obtained a license or until such patent expires.

case, such a license may not be available on commercially reasonable terms or at all.

making intellectual property claims against us may obtain injunctive or other equitable relief, which could block our ability

to further develop and commercialize one or more of our product candidates.

Defense of these claims, regardless of their merit,

involves substantial litigation expense and diversion of our management’s attention from our business.

If a claim of infringement

against us succeeds, we may have to pay substantial damages, possibly including treble damages and attorneys’

fees for willful

infringement, pay royalties, redesign our infringing products or obtain one or more licenses from third parties, which may be

impossible or require substantial time and monetary expenditure.

of the costs involved in defending patent litigation, we currently lack and may in the future lack the capital to defend our intellectual

There may be third-party patents or patent

applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the use or manufacture

of our product candidates.

Because patent applications can take many years to issue, there may be patent applications currently pending

that may later result in patents that our product candidates may infringe upon.

Third parties may obtain patents in the future and claim

that use of our technologies infringes on these patents.

If any third-party patents were to be held by a court of competent jurisdiction

to cover the manufacturing process of any of our product candidates, any molecules formed during the manufacturing process or any final

product itself, the holders of any such patents may be able to block our ability to commercialize such product candidate unless we obtained

a license under the applicable patents, or until such patents expire.

Similarly, if any third-party patents were to be held by a court

of competent jurisdiction to cover aspects of our formulations, processes for manufacture or methods of use, including combination therapy,

the holders of any such patents may be able to block our ability to develop and commercialize the applicable product candidate unless

we obtained a license or until such patent expires.

In either case, such a license may not be available on commercially reasonable terms

making intellectual property claims against us may obtain injunctive or other equitable relief, which could block our ability to further

develop and commercialize one or more of our product candidates.

Defense of these claims, regardless of their merit, involves substantial

litigation expense and diversion of our management’s attention from our business.

If a claim of infringement against us succeeds,

we may have to pay substantial damages, possibly including treble damages and attorneys’ fees for willful infringement, pay royalties,

redesign our infringing products or obtain one or more licenses from third parties, which may be impossible or require substantial time

and monetary expenditure.

of the costs involved in defending patent litigation, we may in the future lack the capital to defend our intellectual

property rights.

depend on intellectual property licensed from third parties in our Coronavirus program and termination of any of these licenses

may in the future be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive,

time-consuming and unsuccessful.

may infringe on our patents or the patents of our licensors.

To counter such infringement or unauthorized use, we may be required to

file infringement claims, or we may be required to defend the validity or enforceability of such patents, which can be expensive and

time-consuming.

In an infringement proceeding, a court may decide that either one or more of our patents or our licensors’ patents

is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue because our patents do not

cover that technology.

An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being

invalidated or interpreted narrowly and could put our patent applications at risk of not issuing.

proceedings provoked by third parties or brought by us may be necessary to determine the priority of inventions regarding our patents

or patent applications or those of our partners or licensors.

An unfavorable outcome could require us to cease using the related technology

or to license rights to it from the prevailing party.

Our business could be harmed if the prevailing party does not offer us a license

on commercially reasonable terms.

Our defense of litigation or interference proceedings may fail and, even if successful, may cause us

to incur substantial costs and distract the attention of our management and other employees.

We may not be able to prevent, alone or

with our licensors, misappropriation of our intellectual property rights, particularly in countries where the laws may not protect those

rights as fully as in the United States.

of the substantial amount of discovery required in intellectual property litigation, there is a risk that some of our confidential information

could be compromised by disclosure during this type of litigation.

There could also be public announcements of the results of hearings,

motions or other interim proceedings or developments.

If securities analysts or investors perceive these results to be negative, it could

have a material adverse effect on the price of our common stock.

depend on intellectual property licensed from third parties in one of our COVID-19 programs and termination of any of these licenses

could have a material adverse effect on our business.

our Coronavirus program we leverage the rights to preclinical leads from our two License Agreements with KSURF.

See “Item

Business –

Research and Development Update –

Coronavirus infections”

for more information on these

License Agreements.

depend on the patents, know-how and other intellectual property, licensed from KSURF for the development and, if approved, commercialization

of our COVID-19 therapy.

If these licenses are terminated, or found to be unenforceable, it could result in the loss of significant

rights and could harm our ability to commercialize our future product candidates in the Coronavirus program.

License Agreements impose certain obligations on us, including obligations to use diligent efforts to meet development thresholds

and payment obligations.

one of our COVID-19 programs, we leverage the rights to preclinical leads from our two License Agreements with KSURF.

1 – Business – Research and Development Update – Coronavirus infections” for more information on these License

depend on the patents, know-how and other intellectual property for the development and, if approved, commercialization of our COVID-19

If these licenses are terminated, or found to be unenforceable, it could result in the loss of significant rights and could

harm our ability to commercialize our future product candidates in the Coronavirus program.

License Agreements impose certain obligations on us, including obligations to use diligent efforts to meet development thresholds and

payment obligations.

Failure by us to comply with such obligations may result in termination of the respective License Agreement.

If KSURF terminates these License Agreements, we may not be able to proceed with our Coronavirus program or discover, develop

KSURF terminates these License Agreements, we may not be able to proceed with that particular Coronavirus program or discover, develop

or commercialize any other product candidates covered by these agreements.

the License Agreements are complex, and contain certain provisions which may be susceptible to multiple interpretations.

disputes may arise between us and our licensors regarding intellectual property subject to a license agreement, including those

scope of rights, if any, granted under the license agreement and other interpretation-related issues;

and to what extent our technology and processes infringe on intellectual property of the licensor that is not subject to the

license agreement;

our licensor or its licensor had the right to grant the license agreement;

third parties are entitled to compensation or equitable relief, such as an injunction, for our use of the intellectual property

without their authorization;

right to sublicense patent and other rights to third parties under collaborative development relationships;

we are complying with our obligations with respect to the use of the licensed technology in relation to our development and

commercialization of product candidates;

involvement in the prosecution and enforcement of the licensed patents and our licensors’

overall patent prosecution

and enforcement strategy;

allocation of ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our

licensors and by us and any future partners or collaborators;

amounts of royalties, milestones or other payments due under the license agreement.

resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights

to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under

the relevant agreement.

disputes may arise between us and our licensors regarding intellectual property subject to a license agreement, including those relating

the scope of rights, if

any, granted under the license agreement and other interpretation-related issues;

whether and to what extent

our technology and processes infringe on intellectual property of the licensor that is not subject to the license agreement;

whether our licensor or

its licensor had the right to grant the license agreement;

whether third parties are

entitled to compensation or equitable relief, such as an injunction, for our use of the intellectual property without their authorization;

our right to sublicense

patent and other rights to third parties under collaborative development relationships;

whether we are complying

with our obligations with respect to the use of the licensed technology in relation to our development and commercialization of product

our involvement in the

prosecution and enforcement of the licensed patents and our licensors’ overall patent prosecution and enforcement strategy;

the allocation of ownership

of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and by us and any future

partners or collaborators;

the amounts of royalties,

milestones or other payments due under the license agreement.

resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the

relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant

may need to obtain additional licenses to intellectual property rights from third parties.

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We may fail to obtain these licenses at a reasonable cost or on reasonable terms, if at all.

In that event, we would be unable

to further develop and commercialize one or more of our product candidates, which could harm our business significantly.

provide any assurances that third-party patents do not exist that might be enforced against our products, resulting in either

an injunction prohibiting our sales, or, with respect to our sales and other activities, an obligation on our part to pay royalties

and/or other forms of compensation to third parties

licensing and acquisition of third-party intellectual property rights is a competitive practice, and companies that may be more

established, or have greater resources than we do, may also be pursuing strategies to license or acquire third-party intellectual

property rights that we may consider necessary or attractive in order to develop and commercialize our product candidates.

established companies may have a competitive advantage over us due to their larger size and cash resources or greater clinical

development and commercialization capabilities.

We may not be able to successfully complete such negotiations and ultimately acquire

the rights to the intellectual property surrounding product candidates that we may seek to acquire, in which case our business

could be harmed.

may in the future be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive,

time-consuming and unsuccessful.

may infringe on our patents or the patents of our licensors.

To counter such infringement or unauthorized use, we may be required

to file infringement claims, or we may be required to defend the validity or enforceability of such patents, which can be expensive

and time-consuming.

In an infringement proceeding, a court may decide that either one or more of our patents or our licensors’

patents is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue because our

patents do not cover that technology.

An adverse result in any litigation or defense proceedings could put one or more of our

patents at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not issuing.

proceedings provoked by third parties or brought by us may be necessary to determine the priority of inventions regarding our

patents or patent applications or those of our partners or licensors.

An unfavorable outcome could require us to cease using the

related technology or to license rights to it from the prevailing party.

Our business could be harmed if the prevailing party

does not offer us a license on commercially reasonable terms.

Our defense of litigation or interference proceedings may fail and,

even if successful, may cause us to incur substantial costs and distract the attention of our management and other employees.

We may not be able to prevent, alone or with our licensors, misappropriation of our intellectual property rights, particularly

in countries where the laws may not protect those rights as fully as in the United States.

of the substantial amount of discovery required in intellectual property litigation, there is a risk that some of our confidential

information could be compromised by disclosure during this type of litigation.

There could also be public announcements of the

results of hearings, motions or other interim proceedings or developments.

If securities analysts or investors perceive these

results to be negative, it could have a material adverse effect on the price of our common stock.

may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential

information of third parties.

In that event, we would be unable to further

develop and commercialize one or more of our product candidates, which could harm our business significantly.

We cannot provide any assurances

that third-party patents do not exist that might be enforced against our products, resulting in either an injunction prohibiting our

sales, or, with respect to our sales and other activities, an obligation on our part to pay royalties and/or other forms of compensation

to third parties

licensing and acquisition of third-party intellectual property rights is a competitive practice, and companies that may be more established,

or have greater resources than we do, may also be pursuing strategies to license or acquire third-party intellectual property rights

that we may consider necessary or attractive in order to develop and commercialize our product candidates.

More established companies

may have a competitive advantage over us due to their larger size and cash resources or greater clinical development and commercialization

capabilities.

We may not be able to successfully complete such negotiations and ultimately acquire the rights to the intellectual property

surrounding product candidates that we may seek to acquire, in which case our business could be harmed.

may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information

of third parties.

employ individuals previously employed at other biotechnology or pharmaceutical companies.

We may be subject to claims asserting

that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed confidential

information of our employees’

former employers or other third parties.

We may also be subject to claims that former employers

or other third parties have an ownership interest in our patents.

We may be subject to claims asserting that

we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed confidential information

of our employees’ former employers or other third parties.

We may also be subject to claims that former employers or other third

parties have an ownership interest in our patents.

Litigation may be necessary to defend against these claims.

There is no guarantee of success in defending these claims, and if we succeed, litigation could cause substantial cost and be

a distraction to our management and other employees.

we face significant competition from other biotechnology and pharmaceutical companies, our operating results will suffer if we

fail to compete effectively.

There is no guarantee

of success in defending these claims, and if we succeed, litigation could cause substantial cost and be a distraction to our management

and other employees.

we face significant competition from other biotechnology and pharmaceutical companies, our operating results will suffer if we fail to

compete effectively.

biotechnology and pharmaceutical industries are intensely competitive.

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including major multinational pharmaceutical companies, biotechnology companies and universities and other research institutions.

Our competitors have substantially greater financial, technical and other resources, such as larger research and development staff

and experienced marketing and manufacturing organizations.

This enables them, among other things, to make greater research and

development investments and efficiently utilize their research and development costs.

Additional mergers and acquisitions in the

biotechnology and pharmaceutical industries may cause even more resources being concentrated in our competitors.

Additionally,

smaller or early-stage companies of which we may not be aware could also prove to be material competitors, particularly through

collaborative arrangements with larger, more well-established companies or by competing with us for limited resources and strategic

alliances with our current or prospective partners.

Competition may increase further because of advances in the commercial applicability

of technologies and greater availability of capital for investment in these industries.

Our competitors may develop, acquire or

license drug products that are more effective or less costly than any product candidate we may develop.

programs we are focusing on are in a preclinical development stage and are targeted toward indications for which there are approved

products on the market or product candidates in clinical development.

We will face competition from other drugs that are or will

be approved for the same therapeutic indications.

Our ability to compete successfully will depend largely on our ability to leverage

our experience in drug discovery and development to:

and develop therapeutics superior to other products in the market;

and retain qualified scientific, product development and commercial personnel;

patent and/or other proprietary protection for our technology platform and product candidates;

required regulatory approvals;

collaborate with pharmaceutical companies in the discovery, development and commercialization of new therapeutics.

availability of our competitors’

products could limit the demand, and the price we can charge, for any products we may develop

competitors have substantially greater financial, technical and other resources, such as larger research and development staff and experienced

marketing and manufacturing organizations.

This enables them, among other things, to make greater research and development investments

and efficiently utilize their research and development costs.

Additional mergers and acquisitions in the biotechnology and pharmaceutical

industries may cause even more resources being concentrated in our competitors.

Additionally, smaller or early-stage companies of which

we may not be aware could also prove to be material competitors, particularly through collaborative arrangements with larger, more well-established

companies or by competing with us for limited resources and strategic alliances with our current or prospective partners.

may increase further because of advances in the commercial applicability of technologies and greater availability of capital for investment

in these industries.

Our competitors may develop, acquire or license drug products that are more effective or less costly than any product

candidate we may develop.

programs we are focusing on are in a preclinical d or early clinical development stage and are targeted toward indications for which

there are approved products on the market or product candidates in clinical development.

We will face competition from other drugs that

are or will be approved for the same therapeutic indications.

Our ability to compete successfully will depend largely on our ability

to leverage our experience in drug discovery and development to:

discover and develop therapeutics

superior to other products in the market;

attract and retain qualified

scientific, product development and commercial personnel;

obtain patent and/or other

proprietary protection for our technology platform and product candidates;

obtain required regulatory

successfully collaborate

with pharmaceutical companies in the discovery, development and commercialization of new therapeutics.

availability of our competitors’ products could limit the demand, and the price we can charge, for any products we may develop

and commercialize.

For example, the widespread distribution of COVID-19 vaccines which the FDA recently authorized for emergency

use will reduce the demand for any therapeutic product we develop to treat symptoms caused by the virus.

We will not achieve our

business plan if the acceptance of our products is inhibited by price competition or the reluctance of physicians to switch from

existing drug products to our products, or if physicians switch to other new drug products or reserve our products for use in

limited circumstances.

Additionally, the biopharmaceutical industry is characterized by rapid technological and scientific change,

and we may not be able to adapt to these rapid changes to the extent necessary to keep up with competitors or at all.

The inability

to compete with existing or subsequently introduced drug products would have a material adverse impact on our business, financial

condition and prospects.

pharmaceutical companies may invest heavily to accelerate discovery and development of novel compounds or to in-license novel

compounds that could make our product candidates less competitive.

Any new product that competes with an approved product must

typically demonstrate advantages, such as in efficacy, convenience, tolerability or safety, to overcome price competition and

Our competitors may obtain patent protection, receive approval by FDA and/or foreign regulatory authorities or discover,

develop and commercialize product candidates before we do, which would have a material adverse impact on our business.

commercial success of our product candidates will depend upon the acceptance of these product candidates by the medical community,

including physicians, patients and healthcare payors.

one or more product candidates achieve regulatory approval and we commence marketing such products, the market acceptance of any

product candidates will depend on several factors, including:

demonstration

of clinical safety and efficacy compared to other products;

relative convenience, ease of administration and acceptance by physicians, patients and healthcare payors;

prevalence and severity of any adverse effects or serious adverse effects;

or warnings in the label approved by FDA and/or foreign regulatory authorities for such products;

timing of market introduction of our products relative to competitive products and the availability of alternative treatments;

and cost-effectiveness;

execution and effectiveness of our or any partners’

sales and marketing strategies;

ability to obtain hospital formulary approval;

ability to obtain and maintain sufficient third-party payor coverage or reimbursement.

we obtain regulatory approval for one product candidate, we expect sales to generate substantially all of our product revenues,

and as such, the failure of these products to find market acceptance would adversely affect our results of operations.

insurance and/or government coverage and adequate reimbursement are not available for our product candidates, it could impair

our ability to achieve and maintain profitability.

For example, the widespread distribution of COVID-19 vaccines will reduce the demand for any therapeutic product we

develop to treat symptoms caused by the virus.

We will not achieve our business plan if the acceptance of our products is inhibited by

price competition or the reluctance of physicians to switch from existing drug products to our products, or if physicians switch to other

new drug products or reserve our products for use in limited circumstances.

Additionally, the biopharmaceutical industry is characterized

by rapid technological and scientific change, and we may not be able to adapt to these rapid changes to the extent necessary to keep

up with competitors or at all.

The inability to compete with existing or subsequently introduced drug products would have a material

adverse impact on our business, financial condition and prospects.

pharmaceutical companies may invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds

that could make our product candidates less competitive.

Any new product that competes with an approved product must typically demonstrate

advantages, such as in efficacy, convenience, tolerability or safety, to overcome price competition and to succeed.

Our competitors may

obtain patent protection, receive approval by FDA and/or foreign regulatory authorities or discover, develop and commercialize product

candidates before we do, which would have a material adverse impact on our business.

commercial success of our product candidates will depend upon the acceptance of these product candidates by the medical community, including

physicians, patients and healthcare payors.

one or more product candidates achieve regulatory approval and we commence marketing such products, the market acceptance of any product

candidates will depend on several factors, including:

demonstration of clinical

safety and efficacy compared to other products;

the relative convenience,

ease of administration and acceptance by physicians, patients and healthcare payors;

the prevalence and severity

of any adverse effects or serious adverse effects;

limitations or warnings

in the label approved by FDA and/or foreign regulatory authorities for such products;

the timing of market introduction

of our products relative to competitive products and the availability of alternative treatments;

pricing and cost-effectiveness;

the execution and effectiveness

of our or any partners’ sales and marketing strategies;

our ability to obtain hospital

formulary approval;

our ability to obtain and

maintain sufficient third-party payor coverage or reimbursement.

we obtain regulatory approval for one product candidate, we expect sales to generate substantially all of our product revenues, and as

such, the failure of these products to find market acceptance would adversely affect our results of operations.

insurance and/or government coverage and adequate reimbursement are not available for our product candidates, it could impair our ability

to achieve and maintain profitability.

acceptance and sales of any product candidates we develop will depend on coverage and reimbursement policies of third-party payors.

Government authorities and third-party payors, such as private health insurers, hospitals and health maintenance organizations,

decide which drugs they will pay for and establish reimbursement levels.

Coverage and adequate reimbursement may not be available

for some or all of our product candidates.

As patients generally rely on third-party payors to reimburse all or part of the costs

associated with their treatment, inadequate reimbursement amounts may reduce the demand for, or the price of, our future products.

Thus, the availability of adequate coverage and reimbursement from governmental healthcare programs, such as Medicare and Medicaid,

and commercial payors is critical to new product acceptance.

authorities and third-party payors, such as private health insurers, hospitals and health maintenance organizations, decide which drugs

they will pay for and establish reimbursement levels.

Coverage and adequate reimbursement may not be available for some or all of our

product candidates.

As patients generally rely on third-party payors to reimburse all or part of the costs associated with their treatment,

inadequate reimbursement amounts may reduce the demand for, or the price of, our future products.

Thus, the availability of adequate

coverage and reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors is critical to

new product acceptance.

coverage and reimbursement approval of a product from a government or other third-party payor is a time-consuming and costly process,

and no uniform policy of coverage and reimbursement for products exists among third-party payors in the United States.

trend in the U.S.

A primary trend

healthcare industry is cost containment.

Third-party payors have attempted to control costs by limiting coverage

and the amount of reimbursement for particular products.

Further, third-party payors are increasingly challenging prices charged

for pharmaceutical products, and many third-party payors may refuse to provide coverage and reimbursement for particular drugs

when an equivalent generic drug or a less expensive therapy is available.

There can be no assurance that coverage and reimbursement

will be available for any product we commercialize.

Even if we obtain coverage for a given product, the resulting reimbursement

payment rates might not be adequate for us to achieve or sustain profitability or may require co-payments that patients find unacceptable.

If reimbursement is not available, or is available at limited levels, we may not be able to successfully commercialize product

candidates we develop.

to the recent change in the United States presidency, we expect increased regulation as well as uncertainty, which may adversely

affect our business.

the inauguration of President Biden, we expect that the FDA, the Centers for Disease Control and other agencies which affect our

business may increase their regulatory efforts.

At the senior administrative level, new regulators with a regulatory zeal may

tighten existing regulations and that approach may also be taken in the routine interactions between staff and our scientists

Increased regulation and enforcement may lead to increased costs and further delays in getting approvals, which may

adversely affect our business.

pressures on our drug candidates, including as the result of proposed legislative changes, may negatively impact our future results

of operations.

have been numerous legislative and regulatory proposals to change the healthcare system in the United States and in some foreign

jurisdictions that could affect our ability to sell products profitably.

President Biden has proposed a new health plan that would

rely on a “Medicare-like”

public option for individuals who are not on Medicare and transition to a Medicare-for-All

Third-party payors have attempted to control costs by limiting coverage and the

amount of reimbursement for particular products.

Further, third-party payors are increasingly challenging prices charged for pharmaceutical

products, and many third-party payors may refuse to provide coverage and reimbursement for particular drugs when an equivalent generic

drug or a less expensive therapy is available.

There can be no assurance that coverage and reimbursement will be available for any product

we commercialize.

Even if we obtain coverage for a given product, the resulting reimbursement payment rates might not be adequate for

us to achieve or sustain profitability or may require co-payments that patients find unacceptable.

If reimbursement is not available,

or is available at limited levels, we may not be able to successfully commercialize product candidates we develop.

to the recent change in the United States presidency, we expect increased regulation as well as uncertainty, which may adversely affect

our business.

President Biden, we expect that the FDA, the Centers

for Disease Control and other agencies which affect our business may increase their regulatory efforts.

At the senior administrative

level, new regulators with a regulatory zeal may tighten existing regulations and that approach may also be taken in the routine interactions

between staff and our scientists and others.

For example, in late calendar year 2021 the White House Office of Management and Budget

issued the Fall 2021 Agency Rule List which contains 85 proposed and final rules that the agency plans to issue under the FDA’s

These rules or other regulatory developments which may occur in the future could have an adverse impact, directly or indirectly,

on our operations or on the operations of our collaborators.

Increased regulation and enforcement may lead to increased costs and further

delays in getting approvals, which may adversely affect our business.

pressures on our drug candidates, including as the result of proposed legislative changes, may negatively impact our future results of

have been numerous legislative and regulatory proposals to change the healthcare system in the United States and in some foreign jurisdictions

that could affect our ability to sell products profitably.

President Biden has expressed support for implementing a new health plan that

would rely on a “Medicare-like” public option for individuals who are not on Medicare and transition to a Medicare-for-All

single payor system in the future.

Among other things, it will seek to:

prescription prices by permitting Medicare to negotiate prices;

price increases;

prices for drugs which do not have competition;

consumers to buy prescriptions from other countries.

changes are subject to Congressional approval and we cannot predict what, if any, of these broad proposals or other legislation

the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designed to

control drug pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access

and marketing cost disclosure and transparency measures.

In addition, regional healthcare authorities and individual hospitals

are increasingly using bidding procedures to determine which pharmaceutical products and suppliers will be included in their prescription

drug and other healthcare programs.

These measures could reduce the ultimate demand for our products, or put pressure on our product

The availability of generic treatments may also substantially increase pricing pressures on, and reduce reimbursement

for, our future products.

The potential application of user fees to generic drug products may expedite approval of additional

generic drug treatments.

We expect to experience additional pricing pressures in connection with the sale of any of our products,

due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative

Among other things, such a system may seek to:

lower prescription prices

by permitting Medicare to negotiate prices;

limit price increases;

set prices for drugs which

do not have competition;

permit consumers to buy

prescriptions from other countries.

Additionally,

in 2021 the Biden administration proposed legislation to implement a number of regulatory changes to make affordable healthcare

available for a larger number of Americans, including by lowering the costs of prescription drugs.

The proposal includes measures that

would allow the government to negotiate prices of certain prescription drugs under Medicare and would redesign the Medicare Part D benefit

to limit patient out-of-pocket drug costs and shift liabilities among stakeholders, including manufacturers.

These changes are subject

to Congressional approval and we cannot predict what, if any, of these broad proposals or other legislation will pass.

the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designed to control

drug pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost

disclosure and transparency measures.

In addition, regional healthcare authorities and individual hospitals are increasingly using bidding

procedures to determine which pharmaceutical products and suppliers will be included in their prescription drug and other healthcare

These measures could reduce the ultimate demand for our products, or put pressure on our product pricing.

The availability

of generic treatments may also substantially increase pricing pressures on, and reduce reimbursement for, our future products.

The potential

application of user fees to generic drug products may expedite approval of additional generic drug treatments.

We expect to experience

additional pricing pressures in connection with the sale of any of our products, due to the trend toward managed healthcare, the increasing

influence of health maintenance organizations and additional legislative changes.

some non-U.S.

jurisdictions, the proposed pricing for a drug must be approved before it may be lawfully marketed.

The requirements

governing drug pricing vary widely from country to country.

The European Union, or EU, provides options for its member states

to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control

the prices of medicinal products for human use.

A member state may approve a specific price for the medicinal product or it may

instead adopt a system of direct or indirect controls on the profitability of the Company placing the medicinal product on the

There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products

will allow favorable reimbursement and pricing arrangements for our products.

Historically, products launched in the EU do not

follow price structures of the U.S.

and tend to be priced significantly lower.

we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our

product candidates, we may be unable to generate any revenues from product sales.

do not have a team with experience in the sales, marketing and distribution of pharmaceutical products and the cost of establishing

and maintaining such an organization may exceed the cost-effectiveness of doing so.

To market any products that may be approved,

we must build our sales, marketing, managerial and other non-technical capabilities or arrange with third parties to perform these

The requirements governing

drug pricing vary widely from country to country.

The European Union, or EU, provides options for its member states to restrict the range

of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal

products for human use.

A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct

or indirect controls on the profitability of the Company placing the medicinal product on the market.

There can be no assurance that

any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing

arrangements for our products.

Historically, products launched in the EU do not follow price structures of the U.S.

and tend to be priced

significantly lower.

we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product

candidates, we may be unable to generate any revenues from product sales.

do not have a team with experience in the sales, marketing and distribution of pharmaceutical products and the cost of establishing and

maintaining such an organization may exceed the cost-effectiveness of doing so.

To market any products that may be approved, we must

build our sales, marketing, managerial and other non-technical capabilities or arrange with third parties to perform these services.

current and future partners may not dedicate sufficient resources to the commercialization of our product candidates or may otherwise

fail in their commercialization efforts due to factors beyond our control.

If we are unable to establish effective alliances to

enable the sale of our product candidates to healthcare professionals and in geographical regions, including the United States,

that will not be covered by our own marketing and sales force, or if our potential future strategic partners do not successfully

commercialize the product candidates, our ability to generate revenues from product sales will be adversely affected.

we are unable to establish adequate sales, marketing and distribution capabilities, whether independently or with third parties,

we may not be able to generate sufficient product revenue and may not become profitable.

We will be competing with many companies

that have extensive and well-funded marketing and sales operations.

Without an internal team or the support of a third-party to

perform marketing and sales functions, we may be unable to compete successfully against these more established companies.

If we are unable to establish effective alliances to enable

the sale of our product candidates to healthcare professionals and in geographical regions, including the United States, that will not

be covered by our own marketing and sales force, or if our potential future strategic partners do not successfully commercialize the

product candidates, our ability to generate revenues from product sales will be adversely affected.

we are unable to establish adequate sales, marketing and distribution capabilities, whether independently or with third parties, we may

not be able to generate sufficient product revenue and may not become profitable.

We will be competing with many companies that have

extensive and well-funded marketing and sales operations.

Without an internal team or the support of a third-party to perform marketing

and sales functions, we may be unable to compete successfully against these more established companies.

we obtain approval to commercialize any approved products outside of the United States, a variety of risks associated with international

operations could materially adversely affect our business.

any of our product candidates are approved for commercialization, we may enter into agreements with third parties to market them

on a worldwide basis or in more limited geographical regions.

We expect we will be subject to additional risks related to entering

into international business relationships, including:

regulatory requirements for drug approvals in foreign countries;

protection for intellectual property rights;

changes in tariffs, trade barriers and regulatory requirements;

weakness, including inflation, or political instability in foreign economies and markets;

with tax, employment, immigration and labor laws for employees living or traveling abroad;

taxes, including withholding of payroll taxes;

currency fluctuations, which could cause increased operating expenses and reduced revenues, and other obligations incident

to doing business in another country;

uncertainty in countries where labor unrest is endemic;

shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;

interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes,

typhoons, floods and fires.

we lose key management or scientific personnel, cannot recruit qualified employees, directors, officers, or other personnel or

experience increases in our compensation costs, our business may materially suffer.

any of our product candidates are approved for commercialization, we may enter into agreements with third parties to market them on a

worldwide basis or in more limited geographical regions.

We expect we will be subject to additional risks related to entering into international

business relationships, including:

different regulatory requirements

for drug approvals in foreign countries;

reduced protection for

intellectual property rights;

unexpected changes in tariffs,

trade barriers and regulatory requirements;

economic weakness, including

inflation, or political instability in foreign economies and markets;

compliance with tax, employment,

immigration and labor laws for employees living or traveling abroad;

foreign taxes, including

withholding of payroll taxes;

foreign currency fluctuations,

which could cause increased operating expenses and reduced revenues, and other obligations incident to doing business in another

workforce uncertainty in

countries where labor unrest is endemic;

production shortages resulting

from any events affecting raw material supply or manufacturing capabilities abroad;

business interruptions

resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and

we lose key management or scientific personnel, cannot recruit qualified employees, directors, officers, or other personnel or experience

increases in our compensation costs, our business may materially suffer.

depend on principal members of our executive and research teams;

the loss of whose services may adversely impact the achievement

of our objectives.

We are highly dependent on our Chairman of the Board and Chief Executive Officer, Dr.

Gary Wilcox, our President,

Sam Lee and our Chief Financial Officer, James Martin.

We do not carry “key-man”

life insurance on any of our

employees or advisors.

Furthermore, our future success will also depend in part on the continued service of our key scientific

and management personnel and our ability to identify, hire, and retain additional personnel.

We may not be able to attract and

retain personnel on acceptable terms, as there is significant competition among numerous pharmaceutical companies for individuals

with similar skill sets.

Because of this competition, our compensation costs may increase significantly.

If we lose key employees,

our business may suffer.

the loss of whose services may adversely impact the achievement of our

We are highly dependent on our President and co-Interim Chief Executive Officer, Dr.

Sam Lee and our Chief Financial Officer

and co-Interim Chief Executive Officer, James Martin, particularly following the passing away of our former Chief Executive Officer and

Chairman of the Board, Dr.

Gary Wilcox, in May 2021.

We may be unable to locate a new Chief Executive Officer capable of running our

company effectively, and any such individual will require high compensation in a competitive market for experienced and qualified personnel

within our industry.

We do not carry “key-man” life insurance on any of our employees or advisors.

Furthermore, our future

success will also depend in part on the continued service of our key scientific and management personnel and our ability to identify,

hire, and retain additional personnel.

We may not be able to attract and retain personnel on acceptable terms, as there is significant

competition among numerous pharmaceutical companies for individuals with similar skill sets.

Because of this competition, our compensation

costs may increase significantly.

If we lose key employees, our business may suffer.

we expand our organization, we may experience difficulties in managing growth, which could disrupt our operations.

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managerial, scientific and operational, commercial, financial and other resources and to hire more consultants and contractors.

Future growth would impose significant additional responsibilities on our management, including the need to identify, recruit,

maintain, motivate and integrate additional employees, consultants and contractors.

Also, our management may need to divert a

disproportionate amount of its attention away from our day-to-day activities and to managing these growth activities.

be able to effectively manage the expansion of our operations, which may cause weaknesses in our infrastructure, and give rise

to operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees.

Our expected growth could require significant capital expenditures and may divert financial resources from other projects, such

as developing additional product candidates.

If our management cannot effectively manage our growth, our expenses may increase

more than expected, our ability to generate and/or grow revenues could be reduced, and we may not be able to implement our business

Our future financial performance and our ability to commercialize product candidates and compete effectively will depend,

in part, on our ability to manage our future growth.

relationships with customers and third-party payors may be subject, directly or indirectly, to federal and state healthcare fraud

and abuse laws, false claims laws and health information privacy and security laws.

If we are unable to comply, or have not fully

complied, with such laws, we could face criminal sanctions, civil penalties, contractual damages, reputational harm and diminished

profits and future earnings.

we obtain FDA approval for any of our product candidates and commercialize those products in the United States, our operations

may be directly, or indirectly through our customers, subject to various federal and state fraud and abuse laws, including, without

limitation, the federal Anti-Kickback Statute and the federal False Claims Act.

These laws may impact, among other things, our

proposed sales, marketing and education programs.

We may be subject to patient privacy regulation by the federal government and

states and foreign jurisdictions in which we conduct our business.

The laws that may affect our ability to operate

federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving,

offering or paying remuneration, directly or indirectly, to induce, or in return for, either the referral of an individual,

or the purchase or recommendation of an item or service for which payment may be made under a federal healthcare program,

such as the Medicare and Medicaid programs;

civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities

from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers

that are false or fraudulent;

federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes

that prohibit executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare

as amended by the Health Information Technology and Clinical Health Act of 2009, or HITECH, and its implementing regulations,

which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health

and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply

to items or services reimbursed by any third-party payer, including commercial insurers, and state and foreign laws governing

the privacy and security of health information in certain circumstances, many of which differ from each other in significant

ways and may not have the same effect, thus complicating compliance efforts.

our operations are found to violate any of the laws described above or any other governmental regulations that apply to us, we

may be subject to penalties, including, without limitation, civil and criminal penalties, damages, fines, possible exclusion from

Medicare, Medicaid and other government healthcare programs, and curtailment or restructuring of our operations, which could adversely

affect our ability to operate our business and our results of operations.

growth would impose significant additional responsibilities on our management, including the need to identify, recruit, maintain, motivate

and integrate additional employees, consultants and contractors.

Also, our management may need to divert a disproportionate amount of

its attention away from our day-to-day activities and to managing these growth activities.

We may not be able to effectively manage the

expansion of our operations, which may cause weaknesses in our infrastructure, and give rise to operational mistakes, loss of business

opportunities, loss of employees and reduced productivity among remaining employees.

Our expected growth could require significant capital

expenditures and may divert financial resources from other projects, such as developing additional product candidates.

If our management

cannot effectively manage our growth, our expenses may increase more than expected, our ability to generate and/or grow revenues could

be reduced, and we may not be able to implement our business strategy.

Our future financial performance and our ability to commercialize

product candidates and compete effectively will depend, in part, on our ability to manage our future growth.

relationships with customers and third-party payors may be subject, directly or indirectly, to federal and state healthcare fraud and

abuse laws, false claims laws and health information privacy and security laws.

If we are unable to comply, or have not fully complied,

with such laws, we could face criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and

future earnings.

we obtain FDA approval for any of our product candidates and commercialize those products in the United States, our operations may be

directly, or indirectly through our customers, subject to various federal and state fraud and abuse laws, including, without limitation,

the federal Anti-Kickback Statute and the federal False Claims Act.

These laws may impact, among other things, our proposed sales, marketing

and education programs.

We may be subject to patient privacy regulation by the federal government and by the U.S.

states and foreign

jurisdictions in which we conduct our business.

The laws that may affect our ability to operate include:

the federal Anti-Kickback

Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,

directly or indirectly, to induce, or in return for, either the referral of an individual, or the purchase or recommendation of an

item or service for which payment may be made under a federal healthcare program, such as the Medicare and Medicaid programs;

federal civil and criminal

false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting,

or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent;

the federal Health Insurance

Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit executing a scheme

to defraud any healthcare benefit program and making false statements relating to healthcare matters;

HIPAA, as amended by the

Health Information Technology and Clinical Health Act of 2009, or HITECH, and its implementing regulations, which imposes certain

requirements relating to the privacy, security and transmission of individually identifiable health information;

state and foreign law equivalents

of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by

any third-party payer, including commercial insurers, and state and foreign laws governing the privacy and security of health information

in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating

compliance efforts.

our operations are found to violate any of the laws described above or any other governmental regulations that apply to us, we may be

subject to penalties, including, without limitation, civil and criminal penalties, damages, fines, possible exclusion from Medicare,

Medicaid and other government healthcare programs, and curtailment or restructuring of our operations, which could adversely affect our

ability to operate our business and our results of operations.

we face potential product liability if claims are brought against us, we may incur substantial liability and costs.

our product candidates in clinical trials and the sale of any products for which we obtain marketing approval exposes us to the

risk of product liability claims.

our product candidates in clinical trials and the sale of any products for which we obtain marketing approval exposes us to the risk

of product liability claims.

Product liability claims might be brought against us by consumers, healthcare providers, pharmaceutical

companies or others selling or otherwise coming into contact with our products.

If we cannot successfully defend against product

liability claims, we could incur substantial liability and costs.

Regardless of merit or eventual outcome, product liability claims

of our business reputation;

of clinical trial participants;

due to related litigation;

of management’s attention from our primary business;

monetary awards to patients or other claimants;

scrutiny and product recalls, withdrawals or labeling, marketing or promotional restrictions;

inability to commercialize our product candidates;

demand for our product candidates, if approved for commercial sale.

If we cannot successfully defend against product liability

claims, we could incur substantial liability and costs.

Regardless of merit or eventual outcome, product liability claims may cause:

impairment of our business

withdrawal of clinical

trial participants;

costs due to related litigation;

distraction of management’s

attention from our primary business;

substantial monetary awards

to patients or other claimants;

regulatory scrutiny and

product recalls, withdrawals or labeling, marketing or promotional restrictions;

the inability to commercialize

our product candidates;

decreased demand for our

product candidates, if approved for commercial sale.

coverage is becoming increasingly expensive and we may not be able to maintain insurance coverage at a reasonable cost or in sufficient

amounts to protect us against losses due to liability.

If and when we obtain marketing approval for product candidates, we intend

to expand our insurance coverage to include the sale of commercial products;

however, we may be unable to obtain product liability

insurance on commercially reasonable terms or in adequate amounts.

Occasionally, large judgments have been awarded in class action

lawsuits based on drugs that had unanticipated adverse effects.

A successful product liability claim or series of claims brought

against us could cause our stock price to decline and, if judgments exceed our insurance coverage, could adversely affect our

results of operations and business.

interruptions resulting from pandemics, natural disasters and adverse weather events could cause delays in research and development

of our product candidates.

If and when we obtain marketing approval for product candidates, we intend to

expand our insurance coverage to include the sale of commercial products;

however, we may be unable to obtain product liability insurance

on commercially reasonable terms or in adequate amounts.

Occasionally, large judgments have been awarded in class action lawsuits based

on drugs that had unanticipated adverse effects.

A successful product liability claim or series of claims brought against us could cause

our stock price to decline and, if judgments exceed our insurance coverage, could adversely affect our results of operations and business.

interruptions resulting from pandemics, natural disasters and adverse weather events could cause delays in research and development of

our product candidates.

principal offices are in Bothell, Washington where we conduct our scientific research.

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office in Miami, Florida.

We are vulnerable to natural disasters such as earthquakes and tornados as well as other events that

could disrupt our operations and cause delays in research and development of our product candidates.

We do not carry insurance

for natural disasters, and we may not carry sufficient business interruption insurance to compensate us for losses that may occur.

In addition, while we do not have offices in Australia, our Influenza A Phase 1 clinical trial in

Australia will depend on one or more CROs and their facilities located in Australia for the furtherance of our research and development

efforts as to that product.

We will also use CROs for our two planned COVID-19 clinical trials.

We and third parties on which we rely

are vulnerable to natural disasters such as earthquakes, tornados, severe storms, hurricanes, tsunamis, and fires, as well as

other events that could disrupt our operations and cause delays in research and development of our product candidates.

We do not carry

insurance for natural disasters or similar events, and we may not carry sufficient business interruption insurance to compensate us for

losses that may occur.

Any losses or damages we incur could have a material adverse effect on our operations.

See also risk factor entitled “Because

of the unknown impact from the COVID-19 pandemic, it may have unanticipated material adverse effect upon us.”

our information technology systems are compromised, the information we store and process, including our intellectual property,

could be accessed, publicly disclosed, lost or stolen, which could harm our business, relationships with strategic partners and

future results of operations.

are increasingly suffering damage from attacks by hackers.

In the ordinary course of business, we store sensitive information,

such as our intellectual property, including trade secrets and results of our clinical and preclinical research, and that of our

suppliers and business partners, on a central server, and such information is transmitted via email correspondence.

What changed 10-K

Item 1A. Risk Factors